Penumbra System PSR3D-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00814548017853), received between Jun 12, 2017 and Aug 6, 2020 — classified as 6 deaths, 10 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Break” (18 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 55 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2020Material Deformation; Material Deformation

  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) AND A VELOCITY DELIVERY MICROCATHETER (VELOCITY). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE PSR3D THROUGH THE VELOCITY AND SUCCESSFULLY COMPLETED ONE PASS USING THE PSR3D. WHILE ATTEMPTING TO MAKE ANOTHER PASS, THE DELIVERY WIRE OF THE PSR3D KINKED AND THE PHYSICIAN WAS UNABLE TO COMPLETE THE SECOND PASS. THEREFORE, THE PSR3D WAS REMOVED. IT WAS REPORTED THAT THE PHYSICIAN ALSO REMOVED THE VELOCITY OUT OF PRECAUTION AND THERE WAS NO NOTED DAMAGE TO THE VELOCITY. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA REVASCULARIZATION DEVICE AND A NEW VELOCITY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10371812 ↗
• InjuryJan 23, 2020Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D), NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND, VELOCITY DELIVERY MICROCATHETER (VELOCITY). DURING THE PROCEDURE, THE PHYSICIAN MADE A PASS USING THE PSR3D, NEURON MAX AND, VELOCITY. WHILE ATTEMPTING TO MAKE ANOTHER PASS, THE PHYSICIAN INSERTED THE PSR3D THROUGH A VELOCITY AND WAS DEPLOYED IN THE MCA WITHOUT ANY ISSUE. HOWEVER, WHILE RETRACTING, THE PHYSICIAN NOTICED THE PSR3D WOULD NOT MOVE AT ALL AND HAD BROKEN OFF IN THE MCA. NO ATTEMPTS WERE MADE TO RETRIEVE THE BROKEN PSR3D AND THE PHYSICIAN ENDED THE PROCEDURE AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

  MAUDE report 9624300 ↗
• MalfunctionNov 20, 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). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A PSR3D OUT OF ITS SHEATH AND REPORTED THAT IT WAS STUCK. IT WAS ALSO REPORTED THAT THE PSR3D APPEARED TO BE SEATED VERY PROXIMAL IN ITS SHEATH. THEREFORE, THE PSR3D WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A SOLITAIRE DEVICE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9350624 ↗
• InjuryAug 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 03-MAY-2019, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) SUPRACLINOID USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7) FROM A PENUMBRA SYSTEM JET 7 KIT AND A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D). DURING THE PROCEDURE, IT WAS REPORTED THAT THE FIRST AND SECOND PASSES USING THE PENUMBRA DEVICES RESULTED IN THE PATIENT''S MTICI FLOW BECOMING GRADE 1; ADDITIONALLY, AND THE THIRD PASS USING THE PENUMBRA DEVICES RESULTED IN THE PATIENT''S MTICI FLOW BECOMING GRADE 2A. ON (B)(6)2019 , THE PATIENT WAS DISCHARGED TO A SKILLED NURSING FACILITY WITH A NIHSS SCORE OF 8. ON(B)(6)2019 , THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT (ED) WITH LEFT SIDED FACIAL DROOP, COUGH, SLURRED SPEECH, AND LEFT SIDED WEAKNESS. THE COMPUTED TOMOGRAPHY ANGIOGRAPHY SCAN (CTA) SHOWED HIGH GRADE STENOSIS OF THE PROXIMAL M2 BRANCH OF THE RIGHT MIDDLE CEREBRAL ARTERY (MCA). THE EVENT WAS CONSIDERED RESOLVED AS OF (B)(6)2019 . THE EVENT WAS ADJUDICATED TO BE A SERIOUS ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO BOTH THE PENUMBRA DEVICES AND THE INDEX PROCEDURE. ON 24-FEB-2020, IT WAS ADJUDICATED THAT THE EVENT WAS NOT CONSIDERED TO BE AN ADVERSE

  Patient problems: Stenosis; Weakness

  MAUDE report 8947395 ↗
• MalfunctionJul 19, 2019Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D), A PENUMBRA SYSTEM JET7 KIT (KIT) AND, A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, WHILE MAKING AN INITIAL PASS USING THE PSR3D WITH THE JET7, NEURON MAX AND, A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ATTEMPTING TO INSERT THE PSR3D INTO A NON-PENUMBRA MICROCATHETER AND, THEREFORE, THE PSR3D WAS RETRACTED BACK INTO THE DELIVERY SHEATH. THE PHYSICIAN THEN ATTEMPTED TO INSERT THE SAME PSR3D, BUT THE SAME ISSUE OCCURRED. THEREFORE, THE PHYSICIAN REMOVED THE PSR3D AND FOUND THE LEADING EDGE OF THE DISTAL TIP TO BE KINKED. THE PROCEDURE WAS COMPLETED USING A NEW PSR3D WITH THE SAME JET7, NEURON MAX AND MICROCATHETER. AFTER THE PROCEDURE, MODERATE VASOSPASM WAS PRESENT IN THE DISTAL LEFT INTERNAL CAROTID ARTERY. IT WAS ALSO REPORTED THAT THE VASOSPASM OCCURRED UPON PLACING THE NEURON MAX. THE VASOSPASM WAS CONSIDERED RESOLVED AS OF 22-JUN-2019.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8805908 ↗
• MalfunctionJun 6, 2019Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D). DURING THE PROCEDURE, THE PSR3D WAS UNABLE TO REMOVE THE CLOT BECAUSE THE FOUR CHAMBERS ON THE PSR3D WERE UNABLE TO OPEN. THEREFORE, THE PSR3D WAS REMOVED, AND THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA STENT RETRIEVER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8676056 ↗
• MalfunctionMar 12, 2019Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 68 HIGH FLOW KIT AND A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D). IT WAS NOTED THAT THE THROMBUS WAS HARD AND COMPACT. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED THE FIRST PASS USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), THEN ATTEMPTED A SECOND PASS USING THE SAME ACE68 WITH A PSR3D. WHILE ATTEMPTING TO RETRACT THE PSR3D BACK INTO THE ACE68 AT THE END OF THE SECOND PASS, THE PHYSICIAN EXPERIENCED RESISTANCE; THEREFORE, THE ACE68 AND PSR3D WERE REMOVED. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE DISTAL TIP OF THE ACE68 HAD COLLAPSED AND THAT ONE OF THE PSR3D PROXIMAL TYNES WAS BENT. THE PROCEDURE WAS COMPLETED USING A NEW ACE68, A NEW PSR3D AND THE SAME NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8412306 ↗
• DeathFeb 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2019 INDICATED THAT THE SERIOUS ADVERSE EVENT WAS UNRELATED TO THE PSR3D AND UNRELATED TO THE PROCEDURE.

  Patient problems: Death; Hematoma; Hemorrhage, Subarachnoid

  MAUDE report 8333033 ↗
• MalfunctionJan 8, 2019Break; Break

  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 INSERTED THE PSR3D THROUGH THE VELOCITY DELIVERY MICROCATHETER (VELOCITY) AND DECIDED TO WITHDRAW IT TO REPOSITION THE VELOCITY. WHILE RE-SHEATHING THE PSR3D, THE PHYSICIAN NOTICED ONE OF THE LEGS HAD SEPARATED FROM THE PUSHER ASSEMBLY. THE PROCEDURE WAS THEREFORE COMPLETED USING A NEW PSR3D 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 8228946 ↗
• MalfunctionSep 28, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D). DURING THE PROCEDURE, THE PSR3D WAS UNABLE TO ADVANCE THROUGH A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC) AFTER A COUPLE OF TURNS PAST THE SKULL BASE. IT WAS NOTED THAT THE PUSHABILITY IN THE PSR3D WAS COMPROMISED; THEREFORE, THE PSR3D AND THE 3MAXC WERE REMOVED AND THE PROCEDURE WAS COMPLETED USING ADDITIONAL DEVICES. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7920644 ↗
• MalfunctionSep 11, 2018Difficult to Advance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A VELOCITY DELIVERY MICROCATHETER (VELOCITY) AND A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY ADVANCING THE PSR3D THROUGH THE VELOCITY AND, THEREFORE, THE PSR3D AND VELOCITY WERE REMOVED. IT WAS REPORTED THAT THE PATIENT¿S VESSELS HAD EXTREME TORTUOSITY AND CALCIFICATION. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER (4MAXC). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7865112 ↗
• DeathAug 22, 2018Break; Physical Resistance/Sticking; Break; 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, THE PHYSICIAN PLACED A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) IN THE TARGET VESSEL, THEN ADVANCED THE PSR3D THROUGH A VELOCITY DELIVERY MICROCATHETER (VELOCITY). HOWEVER, THE THROMBECTOMY WAS UNSUCCESSFUL. WHILE ATTEMPTING TO PULL THE PSR3D INTO THE ACE68, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE PSR3D BROKE OFF FROM ITS DELIVERY WIRE. THE PHYSICIAN ATTEMPTED TO REMOVE THE DETACHED PIECE OF THE PSR3D USING A SNARE DEVICE; HOWEVER, IT WAS UNSUCCESSFUL. THEREFORE, THE PSR3D WAS LEFT IN THE M1 SEGMENT OF THE MCA. IT WAS REPORTED THAT THERE WAS NO NOTED DAMAGE TO THE ACE68 AND THE VELOCITY. THE PATIENT WAS INTUBATED AND DEVELOPED INCREASING SIGNS OF RESPIRATORY FAILURE, AND INABILITY TO HANDLE SECRETIONS. THE PATIENT¿S FAMILY MADE PATIENT COMFORT CARE AND DO NOT RESUSCITATE. THE PATIENT EXPIRED FROM COMPLICATIONS DUE TO STROKE IN THE HOSPICE CARE. THE PHYSICIAN WAS UNABLE TO CONFIRM THE RELATIONSHIP BETWEEN THE PATIENT¿S CAUSE OF DEATH AND THE PSR3D.

  Patient problems: Death

  MAUDE report 7807570 ↗
• DeathAug 2, 2018Material Separation

  PT'S CT SHOWED OCCLUSION OF THE RIGHT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY AND ATHEROSCLEROTIC 80% STENOSIS LEFT ICA ORIGIN. NEUROSURGERY INTERVENTIONALIST WAS CONSULTED. PT INTUBATED FOR AIRWAY MANAGEMENT, AND TAKEN TO OR FOR THROMBECTOMY. CEREBRAL ANGIOGRAM WAS COMPLETED, HOWEVER THROMBECTOMY WAS UNSUCCESSFUL. RIGHT FEMORAL ACCESS, RIGHT CCA AND ICA ANGIOS SHOWED RIGHT M1 OCCLUSION DEPLOYED, DEVICE FAILED WITH SEPARATION AT WIRE JUNCTION. UNABLE TO RETRIEVE DEPLOYED STENT WITH SNARE ATTEMPTS. STENT REMAINED IN PT. UNSUCCESSFUL THROMBECTOMY, NO CHANGE IN FLOW. PHYSICIAN OPERATOR DID NOT USE ANY UNUSUAL FORCE, SLOW REMOVAL UNTIL FELT TENSION RELEASED AND THE WIRE CAME OUT WITHOUT THE ATTACHED STENT. PHYSICIAN NOTIFIED AND SPOKE DIRECTLY WITH MFR REP FOLLOWING THE EVENT. ON (B)(6) 2018 PT INTUBATED. DEVELOPED INCREASING SIGNS OF RESPIRATORY FAILURE, INABILITY TO HANDLE SECRETIONS. ON (B)(6) 2018: FAMILY MADE PT COMFORT CARE, DNR (B)(6) 2018 AT 1:15 AM. PT EXPIRED.

  Patient problems: Death; Occlusion; Respiratory Failure; Stenosis

  MAUDE report 7746406 ↗
• MalfunctionJun 29, 2018Retraction Problem; Physical Resistance; Retraction Problem; Physical Resistance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE BASILAR AND VERTEBRAL ARTERIES USING A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D). IT WAS NOTED THAT THE PATIENT HAD TORTUOUS ANATOMY. DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE RETRACTING THE PSR3D WITHIN THE NON-PENUMBRA MICROCATHETER UNDER ASPIRATION AND, THEREFORE, THE PSR3D WAS RE-SHEATHED WITH A SMALLER NON-PENUMBRA MICROCATHETER. THE PROCEDURE WAS COMPLETED USING A NEW STENT RETRIEVER WITH THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7651897 ↗
• MalfunctionJun 14, 2018Break; Break

  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 PSR3D BROKE OFF FROM ITS PUSHER ASSEMBLY DURING THE THIRD PASS WITH A VELOCITY DELIVERY MICROCATHETER (VELOCITY). THE PSR3D WAS LEFT WITHIN THE PATIENT. NO ATTEMPT WAS MADE TO REMOVE THE PSR3D, AND THERE ARE NO PLANS FOR ADDITIONAL MEDICAL INTERVENTION AT THIS TIME. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7601409 ↗
• MalfunctionJun 11, 2018Bent; Failure to Advance; Physical Resistance; Bent; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 AND M2 SEGMENTS OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D). DURING THE PROCEDURE, THE PHYSICIAN MADE ONE PASS USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68). THE PHYSICIAN THEN ADVANCED A PSR3D TO THE M2 THROUGH A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN WAS UNABLE TO ADVANCE THE ACE68 TO THE M2 AND THEREFORE LEFT THE ACE68 AT THE OPHTHALMIC ARTERY ORIGIN. AFTER ABOUT FIVE MINUTES, THE PHYSICIAN ATTEMPTED TO RETRACT AND REMOVE THE PSR3D, HOWEVER, FELT RESISTANCE AND WAS UNABLE TO. IT WAS REPORTED THAT THE PSR3D FELT CAUGHT ON SOMETHING WITHIN THE PATIENT; HOWEVER, THE PHYSICIAN WAS ABLE TO REMOVE THE PSR3D AFTER FORCEFULLY PULLING IT. UPON REMOVAL, IT WAS NOTED THAT THE PUSHER ASSEMBLY OF THE PSR3D WAS BENT. IT WAS REPORTED THAT THERE WAS NO STENOSIS IN THE VESSEL, AND THE CLOT WAS STILL IN PLACE AFTER THE REMOVAL OF THE PSR3D. THE PROCEDURE WAS THEN COMPLETED USING THE SAME ACE68 AND A NON-PENUMBRA STENT RETRIEVER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7589099 ↗
• MalfunctionApr 27, 2018Device Handling Problem; Device Handling Problem

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE INTRODUCER SHEATH OF A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D) AND A VELOCITY DELIVERY MICROCATHETER (VELOCITY) FELL ON THE FLOOR. THEREFORE, THE PSR3D AND VELOCITY WERE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING NEW PSR3D AND VELOCITY DEVICES.

  Patient problems: No Patient Involvement

  MAUDE report 7470725 ↗
• MalfunctionApr 10, 2018Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D). IT WAS NOTED THAT THE PATIENT HAD A SEVERE MIDDLE CEREBRAL ARTERY (MCA) STENOSIS. DURING THE PROCEDURE, THE PHYSICIAN PLACED A PENUMBRA SYSTEM ACE60 REPERFUSION CATHETER (ACE60), THE ADVANCED A VELOCITY DELIVERY MICROCATHETER (VELOCITY) THROUGH THE ACE60. AFTER THAT, THE PHYSICIAN ADVANCED A PSR3D THROUGH THE VELOCITY. WHILE ATTEMPTING TO RE-SHEATH THE PSR3D AFTER THE FIRST PASS, THE SCRUB TECHNOLOGIST NOTICED THAT ONE OF THE TWO POINTS OF CONNECTION TO THE PSR3D PUSHER¿S ASSEMBLY WAS BROKE. IT IS UNKNOWN IF THE PSR3D WAS BROKEN UPON REMOVAL OR IF THE DAMAGE OCCURRED DURING CLEANING. THEREFORE, THE PHYSICIAN OPENED A NEW PSR3D AND ADVANCED IT INTO THE TARGET VESSEL; HOWEVER, REPERFUSION WAS NOT ACHIEVED. AFTER TWO UNSUCCESSFUL ATTEMPTS, THE PHYSICIAN DECIDED TO REMOVE THE PSR3D. THERE WAS NO REPORTED ISSUE WITH THE PSR3D. THE PROCEDURE WAS COMPLETED USING THE SAME ACE60, VELOCITY, ANOTHER STENT RETRIEVER DEVICE AND ANGIOPLASTY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7419761 ↗
• MalfunctionMar 26, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE CAROTID T ARTERY USING A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A PSR3D THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE PSR3D WOULD NOT ADVANCE; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A DIFFERENT STENT DEVICE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7372054 ↗
• MalfunctionMar 20, 2018Device Damaged Prior to Use; Out-Of-Box Failure; Difficult to Open or Remove Packaging Material; Device Damaged Prior to Use; Out-Of-Box Failure; Difficult to Open or Remove Packaging Material

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D) WOULD NOT COME OUT OF THE DISPENSER HOOP. THE ISSUE WITH THE PSR3D OCCURRED PRIOR TO USE AND THEREFORE, THE PSR3D WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW PSR3D.

  Patient problems: No Patient Involvement

  MAUDE report 7354708 ↗
• MalfunctionMar 12, 2018Bent; Failure to Advance; Bent; 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). IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS VERY TORTUOUS. DURING THE PROCEDURE, WHILE ATTEMPTING TO TRACK A PSR3D THROUGH A 3MAXC, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE PSR3D WOULD NOT ADVANCE AND BECAME BENT; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW PSR3D THROUGH THE 3MAXC; HOWEVER, THE SECOND PSR3D WOULD NOT TRACK EITHER. THEREFORE, THE 3MAXC AND PSR3D WERE REMOVED AND THE PROCEDURE WAS ENDED AT THAT POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7332478 ↗
• MalfunctionMar 12, 2018Failure 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). IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS VERY TORTUOUS. DURING THE PROCEDURE, WHILE ATTEMPTING TO TRACK A PSR3D THROUGH A 3MAXC, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE PSR3D WOULD NOT ADVANCE AND BECAME BENT; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW PSR3D THROUGH THE 3MAXC; HOWEVER, THE SECOND PSR3D WOULD NOT TRACK EITHER. THEREFORE, THE 3MAXC AND PSR3D WERE REMOVED AND THE PROCEDURE WAS ENDED AT THAT POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7332444 ↗
• DeathMar 2, 2018Fracture; Fracture

  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 DID NOT MENTION ANY RESISTANCE WHILE USING THE PSR3D. HOWEVER, THE PSR3D STENT FRACTURED FROM THE PUSHER WIRE ON THE FIRST PASS. THEREFORE, THE PHYSICIAN USED ANOTHER STENT RETRIEVER TO REMOVE THE PSR3D WITH THE THROMBUS ATTACHED. AFTER THE STENT RETRIEVER AND PSR3D WERE REMOVED, AN ANGIOGRAPHY WAS PERFORMED AND REVEALED THAT THE MCA HAD BECOME PERFORATED. HOWEVER, IT IS UNKNOWN WHEN THE PERFORATION OCCURRED AND WHICH DEVICE CAUSED THE PERFORATION. THE PHYSICIAN THEN USED COILS (UNKNOWN MANUFACTURER) TO TREAT THE PERFORATION. THE PATIENT'S CURRENT MEDICAL STATUS IS UNKNOWN.

  Patient problems: Death; Perforation of Vessels

  MAUDE report 7311753 ↗
• MalfunctionFeb 23, 2018Break; Retraction Problem; Physical Resistance; Device Handling Problem; Break; Retraction Problem; Physical Resistance; Device Handling Problem

  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, THE PHYSICIAN ADVANCED A NON-PENUMBRA MICROCATHETER THROUGH A PENUMBRA SYSTEM ACE68 REPERFUSION CATHETER (ACE68), THEN DEPLOYED THE PSR3D THROUGH THE MICROCATHETER. THE PHYSICIAN THEN NOTICED THAT THE PSR3D WAS DEPLOYED IN THE WRONG POSITION AND TRIED TO PULL IT BACK INTO THE MICROCATHETER (PINNED THE MICROCATHETER AND PULLED THE 3D BACK); HOWEVER, RESISTANCE WAS ENCOUNTERED AND THE PSR3D COULD NOT BE PULLED ANY FURTHER. THEREFORE, THE PHYSICIAN LOCKED THE PSR3D DOWN WITH THE ROTATING HEMOSTASIS VALVE (RHV) THAT WAS ON THE BACK OF THE MICROCATHETER AND PULLED BOTH THE PSR3D AND MICROCATHETER BACK THROUGH THE ACE68 AS ONE SYSTEM. UPON REMOVAL, THE PHYSICIAN NOTICED THAT ONE OF THE TINES WAS BROKEN AND SITTING OUTSIDE OF THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING THE SAME ACE68, MICROCATHETER AND ANOTHER STENT RETRIEVER DEVICE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7292204 ↗
• MalfunctionFeb 16, 2018Break; Retraction Problem; Break; Retraction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D). IT WAS NOTED THAT THE PATIENT HAD TIGHT AND TORTUOUS ANATOMY. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO GAIN ACCESS TO THE TARGET LOCATION USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC) OR A VELOCITY DELIVERY CATHETER (VELOCITY) TO DELIVER A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), SO THE PHYSICIAN ADVANCED A PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER (4MAXC). DESPITE MAKING TWO PASSES ASPIRATING WITH THE 4MAXC, THE THROMBUS WAS UNABLE TO BE REMOVED, AND THE PHYSICIAN THEREFORE ATTEMPTED TO USE A PSR3D THROUGH THE 4MAXC. THE PSR3D WAS DEPLOYED WITH THE PROXIMAL MARKER BEYOND THE DISTAL SIDE OF THE CLOT DUE TO THE PATIENT MOVEMENT CAUSING POOR VISIBILITY. THE PHYSICIAN ATTEMPTED TO RETRACT THE PSR3D, HOWEVER THE PSR3D WOULD NOT MOVE. AFTER A FEW ATTEMPTS, THE PSR3D MOVED SLIGHTLY, BUT WAS NOT ABLE TO BE RETRACTED ANY FURTHER. AFTER PULLING ON THE PUSHER WIRE MULTIPLE TIMES, THE PSR3D CONSEQUENTLY DETACHED FROM THE WIRE. THE PHYSICIAN ABORTED THE PROCEDURE SINCE THE PSR3D WAS FIRMLY LODGED AND WOULDN'T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7277065 ↗

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