Penumbra System PSR3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00814548017839), received between Nov 15, 2018 and Mar 19, 2021 — classified as 14 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

1 other recall cover devices cleared under the same FDA submission (K162901); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019 THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE VIA FEMORAL ACCESS USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A PENUMBRA SYSTEM JET7 REPERFUSION CATHETER (JET7), A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D), A PENUMBRA ENGINE (ENGINE), A NON-PENUMBRA MICROCATHETER (MICROVENTION HEADWAY 27), AND HEPARIN ON FLUSHING SYSTEM. DURING THE PROCEDURE THERE WAS COMPLICATIONS BY PERFORATION OF THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) FOLLOWING A STENT RETRIEVER WITHDRAWAL WITH SOME CONTRAST EXTRAVASATION. NO IMMEDIATE COMPLICATIONS NOTED. PERFUSION MRI WAS PERFORMED AND INDICATED COMPLETE LEFT MCA TERRITORY STROKE WITHOUT ADDITIONAL AT-RISK TERRITORY. ALSO, SUBARACHNOID HEMORRHAGE (SAH) WAS PRESENT. THEN, PROTAMINE WAS ADMINISTERED WHICH STOPPED THE CONTRAST EXTRAVASATION BY NEXT RUN OF IMAGES APPROXIMATELY TWO MINUTES LATER. THE PROCEDURE WAS ABORTED, AND AN ANGIOGRAM TAKEN AFTER THE FIRST ATTEMPT AT 23:53 SHOWED THAT NO RECANALIZATION OF M2 MCA WAS ACHIEVED (TICI 0); THERE WAS GOOD FLOW THROUGH M1 SEGMENT OF THE MCA AND SUPERIOR DIVISION. AT 00:03, THE LAST ANGIOGRAM WAS TAKEN AFTER ALL TREATMENT AND IT REVEALED THE FINAL MTICI OF 0. NO ADDITIONAL

  Patient problems: Extravasation; Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels

  MAUDE report 11530805 ↗
• MalfunctionDec 17, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D) AND MICROCATHETER. DURING THE PROCEDURE, THE PSR3D WOULD NOT ADVANCE OUT OF ITS SHEATH AND INTO THE HUB OF THE MICROCATHETER. THEREFORE, THE PSR3D WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA STENT RETRIEVER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11027322 ↗
• InjuryApr 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D), AND A NON-PENUMBRA STENT RETRIEVER DEVICE (PRESET). IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH A LEFT HEMISPHERICAL SYNDROME WITH MOTOR-RELATED APHASIA AND A RIGHT-SIDED LATENT HEMIPARESIS. NO PROCEDURAL COMPLICATIONS WERE REPORTED AND A THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) GRADE 3 RECANALIZATION WAS ACHIEVED. ON (B)(6) 2019, A COMPUTED TOMOGRAPHY (CT) OF THE NEUROCRANIUM PERFORMED AT 09:08 AM REVEALED A HEMORRHAGE INTO THE LEFT INFARCTION AREA AND A SUBARACHNOID HEMORRHAGE (SAH) IN THE LEFT HEMISPHERE AND BLOOD LEVELS IN THE POSTERIOR VENTRICULAR POSTERIOR HORNS. THE PHYSICIAN THEN ADMINISTERED ASPIRIN WITH CLEXANE TO THE PATIENT. A SUBSEQUENT CT OF THE NEUROCRANIUM PERFORMED LATER THE SAME DAY AT 09:06 PM SHOWED THAT THERE WAS NO INCREASE IN THE LEFT FRONTAL BLEEDING AND LEFT HEMISPHERE SAH. WHEN TRANSFERRED TO THE NORMAL WARD, THE PATIENT WAS AWAKE, COOPERATIVE, CALM, 4/5 HEMIPARESIS ON THE RIGHT, NON-FLUID APHASIA WITH NORMAL UNDERSTANDING, SINUS RHYTHM (SR) / CARDIOPULMONARY

  Patient problems: Intracranial Hemorrhage

  MAUDE report 9944932 ↗
• InjuryJan 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D), PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7) AND, PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). ON (B)(6) 2019, A FOLLOW UP 24-HOUR COMPUTERIZED TOMOGRAPHY (CT) SCAN REVEALED EVIDENCE OF THE LEFT MCA INFARCTION WITH SUSPECT CONTRAST STAINING. THIS EVENT IS CONSIDERED RESOLVED WITH CLINICAL SEQUELAE AS OF (B)(6) 2019. THE PROGRESSION OF INDEX STROKE WAS REPORTED TO BE A SERIOUS ADVERSE EVENT RELATED TO THE PSR3D, JET7, 3MAXC AND, THE INDEX PROCEDURE.

  Patient problems: Infarction, Cerebral

  MAUDE report 9623600 ↗
• InjuryOct 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE LEFT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D). NO PROCEDURAL COMPLICATIONS WERE REPORTED. HOWEVER, ON (B)(6) 2019, THE 24 HOUR FOLLOW-UP FORM SHOWED THAT THE PATIENT EXPERIENCED AN ASYMPTOMATIC SUBARACHNOID HEMORRHAGE (SAH) IN THE SYLVIAN FISSURE ON THE LEFT. THE PATIENT WAS TREATED WITH INTRAVENOUS MANNITOL, NIMODIPINE, UNACID ANTIBIOTICS, AND WAS STARTED ON DAILY HEMODIALYSIS BEGINNING ON (B)(6) 2019. HOWEVER, IT WAS REPORTED THAT THE PATIENT ALSO PASSED AWAY ON (B)(6) 2019 DUE TO A MALIGNANT CEREBRAL EDEMA. THE ASYMPTOMATIC SUBARACHNOID HEMORRHAGE WAS ADJUDICATED TO BE A SERIOUS ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE PSR3D AND A PROBABLE RELATIONSHIP TO THE PROCEDURE. THE MALIGNANT CEREBRAL EDEMA AND SUBSEQUENT EXPIRATION OF THE PATIENT WERE ADJUDICATED TO BE UNRELATED TO THE PSR3D.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 9216111 ↗
• MalfunctionSep 11, 2019Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE A1 SEGMENT OF THE ANTERIOR CEREBRAL ARTERY (ACA) USING PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICES (PSR3DS). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PENUMBRA SYSTEM 3MAX REFUSION CATHETER (3MAXC) THROUGH A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), THEN USED A PSR3D TO ENGAGE THE THROMBUS. WHILE RETRACTING THE PSR3D BACK INTO THE 3MAXC, THE PHYSICIAN EXPERIENCED RESISTANCE. AFTER PULLING VERY HARD, THE PHYSICIAN WAS ABLE TO PULL THE PSR3D THROUGH THE 3MAX AND THE JET7. WHILE CLEANING AND PREPARING TO REINTRODUCE THE PSR3D FOR THE SECOND PASS, THE HOSPITAL TECHNOLOGIST NOTICED THE PROXIMAL STRUT CONNECTING THE PSR3D TO THE PUSHER ASSEMBLY WAS BROKEN; THEREFORE, THE PSR3D WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS THEN COMPLETED USING ANOTHER PSR3D, THE SAME 3MAXC AND JET7. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8996858 ↗
• MalfunctionAug 29, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D). IT SHOULD BE NOTED THAT THE PATIENT HAD SEVERELY ELONGATED ARTERIES. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED TENSION WHILE ATTEMPTING TO ADVANCE THE PSR3D TO THE TARGET VESSEL. THE PSR3D WAS THEN REMOVED AND ANOTHER DEVICE WAS USED TO COMPLETE THE FIRST PASS. A TICI GRADE 2C RECANALIZATION WAS THEN ACHIEVED. THEREFORE, THE PHYSICIAN MADE THE DECISION TO END THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8947179 ↗
• MalfunctionAug 15, 2019Material Twisted/Bent; Material Twisted/Bent

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICES (PSR3DS). IT WAS REPORTED THAT THE CLOT WAS VERY TOUGH AND FIBROUS. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED SIX PASSES USING THE ADAPT TECHNIQUE WITH A PENUMBRA SYSTEM JET7 REPERFUSION CATHETER (JET7). HOWEVER, VERY LITTLE CLOT WAS CAPTURED. THEREFORE, THE PHYSICIAN ADVANCED A PSR3D THROUGH THE JET7 AND COMPLETED THREE ADDITIONAL PASSES. AFTER THE THIRD PASS, THE PHYSICIAN NOTICED THE STENT WIRE WAS CURVED, AND THE PSR3D WAS NO LONGER USED. A NEW PSR3D WAS THEN OPENED BUT WAS INADVERTENTLY BENT UPON REMOVAL FROM PACKAGING; THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW PSR3D AND THE SAME JET7. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8899493 ↗
• InjuryAug 5, 2019Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 AND M2 SECTIONS OF THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICES (PSR3DS). IT WAS NOTED THAT A RECOMBINANT TISSUE PLASMINOGEN ACTIVATOR (RTPA) WAS ADMINISTERED PRIOR TO THE PROCEDURE. ADDITIONALLY, A COMPUTED TOMOGRAPHY (CT) SCAN WITHOUT CONTRAST AND A CT ANGIOGRAPHY WERE PERFORMED PRIOR TO THE PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN MADE ONE UNSUCCESSFUL ATTEMPT IN REMOVING THE OCCLUSION USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX (PUMP MAX), NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). THEREFORE, THE PHYSICIAN ADVANCED A PSR3D THROUGH THE 3MAXC AND DEPLOYED IT IN THE TARGET VESSEL TO ENGAGE AND RETRIEVE THE THROMBUS. WHILE RETRACTING THE PSR3D, NO RESISTANCE WAS ENCOUNTERED; HOWEVER, THE PHYSICIAN NOTICED IN THE X-RAY PREVIEW ON THE ANGIOGRAPH THAT THE PSR3D BROKE OFF FROM ITS PULL WIRE IN THE M1/M2. THE PHYSICIAN THEN PERFORMED ANOTHER CT SCAN AND CONFIRMED THAT THE BROKEN PSR3D WAS IN THE M1/M2 AND NOTICED THAT THE THROMBUS WAS NOT IN THE BROKEN PSR3D. THE NEURON MAX

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8860661 ↗
• InjuryJul 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET7 KIT (KIT) AND A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D). DURING THE PROCEDURE, THE PHYSICIAN MADE TWO SUCCESSFUL PASSES USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7) WITH PSR3D, A VELOCITY DELIVERY MICROCATHETER (VELOCITY) AND A NON-PENUMBRA GUIDEWIRE. AFTER MAKING A THIRD AND FINAL PASS WITH THE JET7 AND PSR3D; THE PHYSICIAN NOTICED A RUPTURE UPON REMOVING THE JET7 AND PSR3D. THEREFORE, THE PHYSICIAN ADVANCED A NON-PENUMBRA BALLOON CATHETER AND A GUIDEWIRE; HOWEVER, IT WAS NOT INFLATED. IT WAS DISCOVERED UNDER PRE-INFLATION RUN THAT THE RUPTURE HAD SEALED ITSELF OFF AND CLOSED. THE PROCEDURE HAD ENDED AT THIS POINT. THE PHYSICIAN NOTED THAT THE RUPTURE MAY BE DUE TO PATIENT¿S AGE AND ANATOMY.

  Patient problems: Rupture

  MAUDE report 8809608 ↗
• InjuryJul 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT UNDERWENT A THROMBECTOMY IN THE CAROTID TERMINUS (CAROTID T) USING A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D) AND A PENUMBRA SYSTEM JET7 REPERFUSION CATHETER (JET7). THE PATIENT¿S INITIAL NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) WAS A 11; HOWEVER, THE PRINCIPLE INVESTIGATOR (PI) NOTED THAT THE NIHSS WAS AT 20 LATER IN THE DAY. A STAT COMPUTERIZED TOMOGRAPHY (CT) SHOWS NO BLEED BUT STROKE IN THE RIGHT FRONTAL AND RIGHT PARIETAL LOBE CONSISTENT WITH CT PERFUSION AND CEREBRAL EDEMA. THIS EVENT IS CONSIDERED RESOLVED WITH CLINICAL SEQUELAE AS OF (B)(6) 2019. THESE EVENTS WERE ADJUDICATED TO BE SERIOUS ADVERSE EVENTS WITH A POSSIBLE RELATIONSHIP TO THE JET7 AND PSR3D, AND A POSSIBLE RELATIONSHIP TO THE INDEX PROCEDURE.

  Patient problems: Edema

  MAUDE report 8804914 ↗
• MalfunctionJul 8, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D) AND A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY ADVANCING THE PSR3D THROUGH THE 3MAXC. IT WAS REPORTED THAT THE PSR3D FELT ¿STICKY¿ AND COULD NOT ADVANCE THROUGH THE 3MAXC; THEREFORE, THE 3MAXC AND PSR3D WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW PSR3D AND A NEW 3MAXC. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8768331 ↗
• InjuryJul 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE ON (B)(6) 2019 USING A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D) AND A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET 7), HOWEVER, THERE WAS NO RECANALIZATION DUE TO EXTRAVASATION. THE PATIENT WAS THEN INTUBATED DUE TO DECLINING MENTAL STATUS. A COMPUTED TOMOGRAPHY (CT) SCAN PERFORMED ON (B)(6) 2019 SHOWED AN EVOLVING INFARCT IN THE RIGHT MCA, AND CEREBRAL EDEMA WAS ALSO NOTED BY THE PRINCIPAL INVESTIGATOR (PI). THE CEREBRAL EDEMA WAS MEDICALLY MANAGED AT THAT TIME. THE CT SCAN ALSO REVEALED SUBARACHNOID CONTRAST WAS DECREASING AND, THEREFORE, A SMALL SUBARACHNOID COULD NOT BE EXCLUDED. THE PATIENT WAS TREATED WITH MEDICATION. AS OF (B)(6) 2019, THE EVENT IS STILL ONGOING. THESE EVENTS WERE ADJUDICATED TO BE SERIOUS ADVERSE EVENTS WITH A PROBABLE RELATIONSHIP TO THE INDEX STROKE, INDEX PROCEDURE, PSR3D, AND A POSSIBLE RELATIONSHIP TO THE JET 7.

  Patient problems: Infarction, Cerebral

  MAUDE report 8753135 ↗
• MalfunctionJun 21, 2019Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D). IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS VERY TORTUOUS. AFTER MAKING ONE PASS WITH THE PSR3D AND A NON-PENUMBRA MICROCATHETER, THE TECHNICIAN REMOVED THE PSR3D TO CLEAN OUT THE CLOT AND NOTICED THAT A TINE ON THE PROXIMAL END OF THE PSR3D HAD BECOME BROKEN. THE PSR3D WAS THEREFORE NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS THEN COMPLETED USING A NON-PENUMBRA DEVICE AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8722644 ↗
• InjuryJun 5, 2019Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) AND MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D). DURING THE PROCEDURE, THE PHYSICIAN MADE A SUCCESSFUL PASS USING THE PSR3D WITH A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). WHILE ATTEMPTING TO MAKE A SECOND PASS WITH THE PSR3D, THE PHYSICIAN FELT RESISTANCE AND DECIDED TO RETRACT THE PSR3D. HOWEVER, WHILE RETRACTING, THE PSR3D UNINTENTIONALLY DETACHED IN THE TERMINUS SEGMENT OF THE ICA. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO SUCCESSFULLY REMOVE THE PSR3D. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA STENT RETRIEVER DEVICE WITH THE SAME ACE68 AND NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8672471 ↗
• MalfunctionMay 30, 2019Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED THE PSR3D AND THEN ATTEMPTED TO RETRACT IT INTO THE PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7). HOWEVER, UPON REMOVAL, IT WAS NOTICED THAT THE PSR3D HAD DETACHED FROM ITS PUSHER ASSEMBLY. THE PHYSICIAN THEN FLUSHED THE JET7 OUTSIDE OF THE PATIENT AND FOUND THE PSR3D WITHIN THE JET7. THE PROCEDURE WAS THEN CONTINUED USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND NON-PENUMBRA STENT RETRIEVERS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8655815 ↗
• InjuryMay 24, 2019Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M2 OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D). DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO MAKE A PASS USING THE PSR3D WITH A NON-PENUMBRA MICROCATHETER, HOWEVER, THE STENT BROKE OFF FROM THE PUSHER ASSEMBLY AND REMAINED IN THE M2. IT WAS REPORTED THAT THE STENT DID NOT HOLD ITS SHAPE AND APPEARED THAT SOME OF THE TINES ¿WERE OUTSIDE OF THE M2¿. THEREFORE, THE PHYSICIAN IMPLANTED A NON-PENUMBRA STENT TO STABILIZE THE PSR3D AGAINST THE VESSEL WALL AND RE-PROFUSE THE VESSEL. THE NEXT DAY, THE PATIENT¿S CONDITION WAS STABLE, AND THE MRI SHOWED A SMALL STROKE WITH A RELATIVELY INTACT PENUMBRA. THE VESSEL HAD A TICI 2B FLOW.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8640588 ↗
• MalfunctionMay 10, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D). DURING THE PROCEDURE, A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60) WAS ADVANCED TOGETHER WITH A VELOCITY DELIVERY MICROCATHETER AND A GUIDEWIRE INTO THE TARGET VESSEL. THE VELOCITY WAS THEN POSITIONED DISTAL TO THE THROMBUS AND THE PSR3D WAS ADVANCED THROUGH THE VELOCITY. AS THE PHYSICIAN WAS ADVANCING THE ACE60 OVER THE PSR3D, HE EXPERIENCED RESISTANCE AND REPORTED THAT THE ACE60 WAS UNABLE TO ADVANCE UP TOWARDS THE PSR3D. THE PHYSICIAN THEN DECIDED TO REMOVE THE PSR3D, AND THE DEVICE WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SAME ACE60 AND THE SAME VELOCITY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8601937 ↗
• MalfunctionApr 26, 2019Material Twisted/Bent; Material Twisted/Bent

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE PUSHER ASSEMBLY OF THE PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D) BECAME BENT ON THE BACK TABLE WHILE ATTEMPTING TO ADVANCE THE PSR3D. THE DAMAGE TO THE PSR3D WAS FOUND PRIOR TO USE AND, THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW PSR3D AND A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68).

  Patient problems: No Patient Involvement

  MAUDE report 8556553 ↗
• InjuryApr 5, 2019Retraction Problem; Retraction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE CAROTID T SEGMENT USING PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D) AND PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED INTRA-PROCEDURAL VASOSPASM USING THE PSR3D; THEREFORE, THE PHYSICIAN INJECTED 100 MCG OF INTRA-ARTERIAL NITROGLYCERIN INTO THE LEFT INTERNAL CAROTID ARTERY (ICA) FOR TREATMENT OF THE STENT INDUCED LEFT MIDDLE CEREBRAL ARTERY (MCA) VASOSPASM WHICH RESULTED IN RESOLUTION OF THE VASOSPASM. IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED WHILE PULLING BACK THE PSR3D FROM THE LEFT MIDDLE CEREBRAL ARTERY (MCA). THIS EVENT WAS CONSIDERED RESOLVED ON (B)(6) 2019. THE INTRA-PROCEDURAL VASOSPASM WAS ADJUDICATED TO BE AN ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE JET7, PSR3D AND A DEFINITE RELATIONSHIP TO THE INDEX PROCEDURE.

  Patient problems: Vasoconstriction

  MAUDE report 8487434 ↗
• InjuryFeb 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3D REPERFUSION CATHETER (PSR3D). DURING THE PROCEDURE, THE PHYSICIAN USED A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) TO ASPIRATE TWICE WITH THE PSR3D. THE PHYSICIAN THEN ASPIRATED TWICE WITH A NON-PENUMBRA STENT RETRIEVER IN THE ANTERIOR CEREBRAL ARTERY (ACA) AND THE POSTERIOR CEREBRAL ARTERY (PCA), THROUGH THE POSTERIOR COMMUNICATING ARTERY (PCOM). AFTER THE PROCEDURE, THE PATIENT HAD A TICI 3, AND WAS ADMITTED INTO THE STROKE UNIT. THE PATIENT REMAINED WITH LEFT HEMIPLEGIA AND A GOOD LEVEL OF CONSCIOUSNESS. IT WAS REPORTED THAT THE PATIENT HAD A MIDLINE DISPLACEMENT OF APPROXIMATELY 6 MM. IN THE MORNING ON (B)(6) 2018, THE PATIENT¿S CONDITION WORSENED, AND THE PATIENT HAD A TENDENCY FOR SLEEPINESS. IT WAS REPORTED THAT A COMPUTED TOMOGRAPHY (CT SCAN) WAS TAKEN, AND A HEMORRHAGIC TRANSFORMATION OF THE RIGHT MCA INFARCTION WAS DETERMINED. LATER IN THE DAY, THE PATIENT GLASGOW COMA SCALE (GCS) STARTED TO DECLINE TO 9 AND THE PATIENT EXPERIENCED CONTINUED NEUROLOGICAL DETERIORATION INTO THE EVENING, REQUIRING ENDOTRACHEAL INTUBATION.

  Patient problems: Intracranial Hemorrhage; Paresis

  MAUDE report 8299566 ↗
• InjuryDec 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D). IT WAS NOTED THAT THE PATIENT RECEIVED TISSUE PLASMINOGEN ACTIVATOR (TPA) PRIOR TO BEING TRANSFERRED TO THE HOSPITAL. DURING THE PROCEDURE, WHILE USING THE PSR3D AND A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD), THE PATIENT HAD MULTIPLE EPISODES OF VOMITING AND THE PROCEDURE ULTIMATELY HAD TO BE STOPPED WITHOUT SUCCESSFUL CLOT RETRIEVAL AS THE RISK FOR ASPIRATION BECAME TOO HIGH. THE PATIENT WAS THEN INTUBATED AND TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) FOR FURTHER CARE. POST PROCEDURE, A DETERIORATION OF NEUROLOGICAL STATUS WAS NOTED WITH A CHANGE IN THE NATIONAL INSTITUTES OF HEALTH (NIH) STROKE SCALE FROM 8 TO 22. ADDITIONALLY, A POST PROCEDURE IMAGING REVEALED TWO AREAS OF SYMPTOMATIC INTRACRANIAL HEMORRHAGE (ICH) LIKELY RELATED TO BOTH PROCEDURE AND PRE-PROCEDURE TPA. THE SYMPTOMATIC INTRACRANIAL HEMORRHAGE WAS REPORTED TO BE A SERIOUS ADVERSE WITH A POSSIBLE RELATIONSHIP TO THE PSR3D AND DEFINITE RELATIONSHIP TO THE INDEX PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 8182818 ↗
• InjuryDec 18, 2018Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D). DURING THE PROCEDURE, THE PHYSICIAN MADE TWO SUCCESSFUL PASSES USING THE PSR3D WITH A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND A VELOCITY DELIVERY MICROCATHETER (VELOCITY). DURING THE THIRD PASS, WHILE RETRACTING THE PSR3D, THE PHYSICIAN NOTICED THAT THE PSR3D HAD DETACHED FROM ITS PUSHER ASSEMBLY. THEREFORE, THE PHYSICIAN USED ANOTHER PSR3D TO REMOVE THE DETACHED PSR3D FROM THE PATIENT¿S BODY. THE PROCEDURE WAS COMPLETED USING THE SECOND PSR3D WITH THE SAME VELOCITY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8176186 ↗
• MalfunctionDec 4, 2018Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF FOUND THAT THE PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D) WAS KINKED UPON REMOVAL FROM ITS PACKAGING. THE DAMAGE TO THE PSR3D WAS FOUND PRIOR TO USE AND, THEREFORE, IT WAS REMOVED AND WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A STENT RETRIEVER.

  Patient problems: No Patient Involvement

  MAUDE report 8130554 ↗
• MalfunctionNov 24, 2018Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D). DURING THE PROCEDURE, WHILE USING A PSR3D WITH A VELOCITY DELIVERY MICROCATHETER (VELOCITY) AND A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), THE PSR3D BECAME DETACHED FROM ITS PUSHER WIRE AND REMAINED IN THE MCA. THE PROCEDURE WAS COMPLETED BY USING THE JET7 TO ASPIRATE THE THROMBUS. THERE WAS NO NOTED DAMAGE TO THE VELOCITY AND JET7 AFTER REMOVAL. ADDITIONALLY, THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8100123 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162901. One submission often covers many models, so check the product and lot details in each record.

• Z-2702-2017 · Jun 9, 2017 · Terminated
  Penumbra 3D Revascularization Device It is indicated for used in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disea