AMPLATZER™ 9-AVP2-014Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00811806010403), received between Oct 29, 2019 and Apr 3, 2026 — classified as 6 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (7 reports).

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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2026Premature Separation

  IT WAS REPORTED THAT ON (B)(6) 2026, A 14MM AMPLATZER VASCULAR PLUG 2 WAS CHOSEN FOR IMPLANT USING UNKNOWN DELIVERY SYSTEM. THE DEVICE WAS SELECTED DURING A TWO-DEBRANCH THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) PROCEDURE FOR SUBCLAVIAN ARTERY EMBOLIZATION. DURING ADVANCEMENT OF THE AVP2 THROUGH THE SHEATH, DETACHMENT OF THE PUSHER WIRE FROM THE DISTAL MESH OCCURRED WITHIN THE SHEATH. AS RETRIEVAL FROM WITHIN THE SHEATH WAS DIFFICULT, THE ENTIRE SHEATH WAS REMOVED FROM THE PATIENT, AND THE SYSTEM WAS RETRIEVED OUTSIDE THE BODY. THE SHEATH WAS SUBSEQUENTLY REINSERTED, AND A NEW 14MM AVP2 WAS OPENED AND PREPARED. THE NEWLY OPENED DEVICE WAS DELIVERED TO THE TARGET SITE WITHOUT ISSUE AND WAS SUCCESSFULLY IMPLANTED. THE PHYSICIAN WAS INFORMED OF THE EVENT AND CONFIRMED THAT NO ROTATION WAS APPLIED DURING PREPARATION OR DELIVERY, IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE, AND THAT ALL PREPARATORY STEPS, INCLUDING FLUSHING, WERE PROPERLY PERFORMED. A POSSIBLE CAUSE CONSIDERED WAS UNINTENDED ROTATION OF THE PUSHER WIRE OR THE LOADER PORTION AT SOME POINT PRIOR TO OR DURING INSERTION OR ADVANCEMENT THROUGH THE SHEATH, WHICH MAY HAVE LED TO DETACHMENT; HOWEVER, THERE IS ALSO A POSSIBILI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24780449 ↗
• MalfunctionDec 8, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 14MM AMPLATZER VASCULAR PLUG 2 WAS CHOSEN FOR IMPLANT USING AN UNKNOWN DELIVERY SYSTEM FOR AN ENDO LEAK CASE. DURING THE PROCEDURE, WHILE DEPLOYING, THE PHYSICIAN NOTICED THAT THE DEVICE DEFORMED INTO COBRA-LIKE DEFORMATION. THEREFORE, THE DEVICE WAS RETRIEVED OUT FROM THE PATIENT'S BODY. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE. THERE WAS NO INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WERE NOTICED IN THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED USING A 16MM AMPLATZER VASCULAR PLUG 2. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23751108 ↗
• MalfunctionJul 17, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22533019 ↗
• MalfunctionJun 24, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 14MM AMPLATZER VASCULAR PLUG 2 WAS SELECTED FOR IMPLANT USING AN UNKNOWN SIZED ABBOTT DELIVERY SYSTEM. DURING IMPLANT, THE PLUG WAS DEPLOYED, HOWEVER THE PLUG DEFORMED WITH A COBRA SHAPE. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WAS OBSERVED WITH THE DELIVERY SYSTEM. THE PLUG WAS NEVER RELEASED FROM THE DELIVERY CABLE AND REMOVED FROM THE PATIENT. NO DEVICE WAS ULTIMATELY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22324794 ↗
• MalfunctionMay 21, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON 24 APRIL 2025, A 14MM AMPLATZER VASCULAR PLUG II WAS CHOSEN IN TUBULAR ENDO-LEAK CASE. DURING PROCEDURE, THE DEVICE HAD A COBRA DEFORMATION NOTED WHEN HAVE TAKEN THE PLUG OUT. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WAS NO REPORT OF ANY INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO REPORT OF ANY ANGULATION/KINK NOTICED WITH THE DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THERE WAS NO REPLACEMENT DEVICE IMPLANTED AND THE PROCEDURE GOT TERMINATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22060817 ↗
• InjuryApr 28, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT (B)(6) 2025, A 14MM AMPLATZER VASCULAR PLUG 2 WAS CHOSEN FOR A PROCEDURE. THE DEVICE WAS IMPLANTED. FIFTEEN MINUTES AFTER THE PROCEDURE, IT WAS NOTED THAT THERE WAS STILL FLOW. THE PLUG WAS EXPLANTED AND A NEW 16MM AMPLATZER VASCULAR PLUG 2 WAS CHOSEN AND COMPLETED THE PROCEDURE. THE PHYSICIAN MENTIONED THE REASON FOR SHUNT WAS MIS-SIZING AND THERE WAS NO ADDITIONAL PRODUCT EXPERIENCE NOTED. THE PATIENT'S FINAL OUTCOME WAS SATISFACTORY AND THERE WAS NO REPORTED PATIENT EFFECTS. THE PATIENT WAS REPORTED RECOVERING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919947 ↗
• InjuryApr 25, 2025Migration or Expulsion of Device; Off-Label Use; Migration or Expulsion of Device; Off-Label Use

  IT WAS REPORTED THAT ON (B)(6) 2025, A 23MM NAVITOR VISION VALVE WAS CHOSEN FOR IMPLANT USING AN UNKNOWN DELIVERY SYSTEM. THE PATIENT HAD A NON-ABBOTT SURGICAL AORTIC VALVE WAS IMPLANTED IN 2012 AND 23MM PORTICO VALVE WAS IMPLANTED IN THE NON-ABBOTT VALVE ON AN UNKNOWN DATE IN 2020. ON AN UNKNOWN DATE, THE PATIENT PRESENTED WITH WORSENING DYSPNEA AND A VALVE FAILURE WAS NOTED. DURING PROCEDURE, THE CASE WENT AS PLANNED AND THE VALVE WAS SUCCESSFULLY IMPLANTED. A SMALL LEAK WAS NOTED AFTER IMPLANT AND A POST DILATATION BALLOON WAS REQUESTED TO ACHIEVE OPTIMAL APPOSITION OF THE IMPLANT. A VALVE FRACTURE OF THE SURGICAL VALVE PERFORMED AND THE SURGICAL VALVE FRACTURED. AN AORTOGRAM WAS PERFORMED AFTER VALVE FRACTURE SHOWED A VENTRICULAR SEPTAL DEFECT (VSD) WAS EVIDENT AND A UNKNOWN SIZE AMPLATZER VASCULAR PLUG II (AVP2) WAS CHOSEN TO CLOSE VSD. THE AVP2 PLUG CLOSED THE VSD BUT WAS NOT SECURE. A NEW 25MM NAVITOR VISION WAS IMPLANTED AND THAT SANDWICHED THE PLUG TO SECURE IT. THE VSD REMAINED CLOSED AND PATIENT REMAINED HEMODYNAMICALLY STABLE. THE PATIENT HAD A CONDUCTION DISTURBANCE FOLLOWING THE PROCEDURE AND A TEMPORARY PACING WIRE WAS LEFT IN THE ORIGINAL PLACE. ON (B)(6) 2024, THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21910838 ↗
• InjuryMar 28, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  CLINICAL INFORMATION: (B)(6) - PARADIGM, PATIENT SITE ID: (B)(6) (R902107001, R9020225010). IT WAS REPORTED THAT ON (B)(6) 2025, A 14X5MM AMPLATZER VALVULAR PLUG 3 WAS IMPLANTED IN A PATIENT ALONG WITH A 14MM AMPLATZER VASCULAR PLUG 2. IT WAS NOTED THAT THE 14X5MM AMPLATZER VALVULAR PLUG 3 HAD TO BE PERCUTANEOUSLY EXPLANTED DUE TO AN UNKNOWN DEVICE MALFUNCTION. IT'S ALSO NOTED THAT THE 14MM AMPLATZER VASCULAR PLUG 2 HAD MIGRATED. THE DECISION WAS MADE TO IMPLANT A SECOND 12MM AMPLATZER VASCULAR PLUG 2.

  Patient problems: Insufficient Information

  MAUDE report 21721123 ↗
• MalfunctionJan 3, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 14MM AMPLATZER VASCULAR PLUG II WAS SELECTED FOR IMPLANT ON (B)(6) 2024 USING AN UNKNOWN NON-ABBOTT DELIVERY SYSTEM TO TREAT A TUBULAR ENDOLEAK. DURING IMPLANT THE PLUG TOOK ON A COBRA SHAPE. THE PLUG WAS NOT RELEASED FROM THE DELIVERY CABLE. THE PLUG WAS REMOVED FROM THE PATIENT. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES. THERE WERE NO ANGULATIONS OR KINKS NOTED ON THE DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WERE NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21072569 ↗
• MalfunctionOct 11, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 14MM AMPLATZER VASCULAR PLUG 2 WAS SELECTED FOR AN IMPLANT IN A TAVI PROCEDURE TO PREVENT ENDOLEAK. DURING THE PROCEDURE, THE DEVICE MALFORMATION DURING DEPLOYMENT. THE PHYSICIAN TOOK THE DEVICE OUT OF PATIENT BODY. NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM IT IS UNKNOWN IF A NEW DEVICE WAS IMPLANTED. THERE WAS NO HARM TO PATIENT IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20431169 ↗
• InjuryOct 10, 2023Off-Label Use; Patient Device Interaction Problem; Off-Label Use; Patient Device Interaction Problem

  THE ARTICLE, "EMBOLIZATION USING A DEBRANCH LEFT COMMON CAROTID ARTERY STUMP FOR GUTTER ENDOLEAK AFTER THORACIC ENDOVASCULAR AORTIC REPAIR WITH THE DOUBLE-DEBRANCHING AND CHIMNEY TECHNIQUE", WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF AN 88-YEAR-OLD MALE WHO UNDERWENT THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) WITH DOUBLE-DEBRANCHING AND CHIMNEY TECHNIQUE FOR AORTIC ARCH ANEURYSM. IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 14MM AMPLATZER VASCULAR PLUG II WAS CHOSEN FOR IMPLANT TO EMBOLIZE THE LEFT SUBCLAVIAN ARTERY DURING A CONCOMITANT TEVAR WITH DOUBLE-DEBRANCHING AND CHIMNEY TECHNIQUE PROCEDURE. POST-PROCEDURE IT WAS NOTED THERE WAS A RESIDUAL SHUNT. A DECISION WAS MADE FOR REINTERVENTION AND A SHEATH WAS PLACED AT THE STUMP AND AN ANGIOGRAPHIC CATHETER AND GUIDEWIRE WERE USED TO RETROGRADE CANNULATE THE GUTTER BESIDE THE CHIMNEY GRAFT, AND COIL EMBOLIZATION WAS PERFORMED. THE ARTICLE CONCLUDED THAT EMBOLIZATION FROM A DEBRANCHED LEFT COMMON CAROTID ARTERY STUMP IS USEFUL FOR ENDOLEAKS AFTER TEVAR EMPLOYING THE CHIMNEY AND DEBRANCHING TECHNIQUE. [THE PRIMARY AUTHOR WAS YU KAWAHARA, DEPARTMENT OF CARDIOVASCULAR SURGERY, YAMAGATA PREFECTURAL CENTRAL HOSPITAL, YAMAGATA, JAP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17904861 ↗
• MalfunctionMay 10, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 12MM AMPLATZER VASCULAR PLUG II (8855126) WAS CHOSEN FOR IMPLANT USING A 6F NON-ABBOTT DELIVERY SHEATH. A 5F NON-ABBOTT SECONDARY SHEATH WAS INSERTED INTO THE 6F NON-ABBOTT SHEATH AS A SECONDARY CATHETER. A 0.035" GUIDEWIRE WAS ADVANCED INTO THE PULMONARY ARTERY SIDE OF THE PATIENT DUCTUS ARTERIOSUS AND THE 6F NON-ABBOTT SHEATH WAS DELIVERED. AFTER THE 12MM PLUG WAS DEPLOYED, IT WAS CONFIRMED THAT THE DEVICE WAS TOO SMALL FOR THE DEFECT AND THE DEVICE WAS REMOVED FROM PATIENT BODY. THE 12MM PLUG WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. A 14MM AMPLATZER VASCULAR PLUG WAS THEN CHOSEN FOR IMPLANT. WHEN THE 14MM DEVICE WAS DEPLOYED INSIDE THE PATIENT, THE THIRD DISC OF THE DEVICE APPEARED TO BE EXPANDED. THE DEVICE WAS THEN REMOVED, WHEN IT WAS DEPLOYED OUTSIDE THE PATIENT BODY, THE THIRD DISC SHAPE WAS DIFFERENT THAN USUAL. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WAS NO REPORT OF ANY INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO REPORT OF ANY ANGULATION/KINK NOTICED WITH THE DELIVERY SYSTEM. A NEW 14MM AMPLATZER VASCULAR PLUG II (8840855) WAS THEN CH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16906549 ↗
• MalfunctionMar 24, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT ON (B)(6) 2023, A 14MM AMPLATZER VASCULAR PLUG II WAS SELECTED FOR IMPLANTATION USING A NON-ABBOTT SHEATH. DURING PROCEDURE, THE DEVICE WAS ATTEMPTED TO BE PUSHED INTO THE GUIDING SHEATH, AND THE PLUG WAS OBSERVED TO BE COMPLETELY UNATTACHED FROM THE DELIVERY CABLE. THE DEVICE REMAINED WITHIN THE SHEATH AND WAS NEVER DEPLOYED FROM THE DELIVERY SHEATH WHILE IN THE PATIENT. THE PLUG WAS NOT ABLE TO BE REATTACHED. THE DEVICE WAS NOT IMPLANTED INTO THE PATIENT. THERE WAS NO DAMAGE TO THE PRODUCT BOX OR DEVICE PACKAGING. ANOTHER AMPLATZER VASCULAR PLUG II WAS SUCCESSFULLY IMPLANTED INTO THE PATIENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PATIENT STATUS WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16613083 ↗
• MalfunctionDec 14, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON(B)(6)2022, A 14MM AMPLATZER VASCULAR PLUG II (AVP2) WAS CHOSEN FOR IMPLANT. IN ORDER TO REPAIR A LEAK IN THE INTERNAL ILIAC ARTERY (IIA), AND TO PREVENT TYPE 2 ENDOLEAK AS A COMPLICATION OF ENDOVASCULAR ANEURYSM REPAIR (EVAR), THE RIGHT IIA EMBOLISM SITE WAS APPROACHED FROM THE LEFT COMMON FEMORAL ARTERY WITH A 6F NON-ABBOTT (TERUMO DESTINATION) GUIDING SHEATH CROSSOVER. THE 14MM AVP2 WAS INSERTED INTO THE GUIDING SHEATH AND A DELIVERY WAS ATTEMPTED. IT WAS ABANDONED DUE TO STRONG RESISTANCE NEAR THE RIGHT COMMON ILIAC ARTERY. THERE WAS NO ATTEMPT TO RELEASE THE DEVICE AT THIS TIME. THE AVP2 WAS REPLACED WITH A PENUMBRA MANUFACTURED COIL. THE PENUMBRA MANUFACTURED COIL WAS CHANGED TO A 0.035" POD COIL AND THE RIGHT IIA WAS SUCCESSFULLY EMBOLIZED. THE PHYSICIAN SUGGESTED, BASED ON EXPERIENCE, THAT THE PROBLEM MAY LIE WITH THE SPECIFIC AVP2 USED. THERE WERE NO ADVERSE PATIENT EFFECTS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15977384 ↗
• InjuryMay 20, 2022Migration or Expulsion of Device; Premature Separation; Migration or Expulsion of Device; Premature Separation

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14459778 ↗
• MalfunctionDec 15, 2020Difficult to Insert; Material Twisted/Bent; Difficult to Insert; Material Twisted/Bent

  ON (B)(6) 2020, A 14MM AMPLATZER VASCULAR PLUG II(AVPII) WAS SELECTED FOR EMBOLIZATION IN THE LEFT INTERNAL ILIAC ARTERY VIA THE RIGHT FEMORAL ARTERY. WHEN THE AVPII WAS ATTEMPTED TO INSERT INTO A 6FR FLEXOR ANSEL GUIDING SHEATH(BY COOK MEDICAL), THERE WAS LARGE RESISTANCE FELT ADVANCING THE AVPII FROM THE LOADER NEAR THE CATHETER HUB; THE AVPII COULD NOT BE INSERTED INTO THE GUIDING SHEATH. WHEN THE AVPII WAS REMOVED, AND CONFIRMED OUTSIDE OF THE PATIENT BODY, ABOUT 10MM AWAY FROM THE TIP OF THE PUSHER WIRE WAS FOUND TO HAVE KINKED. A 14MM AMPLATZER VASCULAR PLUG(AVP) WAS USED INSTEAD AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. OTHER THAN THE PROCEDURE DELAY, THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. ALTHOUGH THERE MIGHT BE POSSIBILITY OF THE GUIDING SHEATH LUMEN BEING FLAT, THERE WAS NO VESSEL TORTUOSITY WHERE THE LOADER AND THE CATHETER HUB WAS PLACED INSIDE THE PATIENT, AND THEREFORE, THE PHYSICIAN DOES NOT THINK THE CATHETER LUMEN SHAPE WAS THE CAUSE, BUT DETAILS ARE UNKNOWN. BESIDES, THE REPLACEMENT AVP WAS ABLE TO DELIVER THROUGH THE SHEATH WITHOUT ANY RESISTANCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11011096 ↗
• MalfunctionJun 8, 2020Inflation Problem; Activation Failure; Inflation Problem; Activation Failure

  ON (B)(6) 2020, A 14MM AMPLATZER VASCULAR PLUG II(AVPII) WAS SELECTED FOR EMBOLIZATION OF IIA(INTERNAL ILIAC ARTERY) VIA FEMORAL APPROACH, USING A GUIDING SHEATH(DESTINATION BY TERUMO). THE DISTAL LOBE OF THE THREE LOBES WAS DEPLOYED NORMALLY. HOWEVER, THE DISTAL PART OF THE MID LOBE DID NOT EXPAND. THE AVPII WAS WITHDRAWN INTO THE SHEATH AND RE-DEPLOYED A FEW TIMES, BUT THE ISSUE PERSISTED. ANOTHER 14MM AVPII WAS ABLE TO BE DEPLOYED NORMALLY TO EMBOLIZE THE ARTERY SUCCESSFULLY. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCE TO THE PATIENT. WHEN THE AVPII WAS CHECKED OUTSIDE OF THE PATIENT AFTER THE PROCEDURE, THE AVPII EXPANDED WITH NO PROBLEM. ALTHOUGH THE ISSUE WAS NOT DUPLICATED OUTSIDE OF THE PATIENT, THE PHYSICIAN AND THE SALES REP. THOUGHT THE ISSUE WAS DUE TO THE AVPII ITSELF, FOR THE REPLACEMENT AVPII WAS ABLE TO BE DEPLOYED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10127501 ↗
• InjuryOct 29, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2019, A 14MM AMPLATZER VASCULAR PLUG II WAS SELECTED FOR IMPLANTED TO EMBOLIZE THE GRAFT FROM THE AORTA INTO THE LVAD (MDT HEARTMATE). THE PLUG WAS POSITIONED AND OPTIMALLY RELEASED. THE PATIENT HAD A HIGH QUICK AND THE BLOOD CLOTTING WAS OPTIMIZED; HOWEVER, AFTER 60 MINUTES THE VESSEL WAS NOT COMPLETELY EMBOLIZED AFTER 60 MINUTES. THE PATIENT WAS THEN BROUGHT TO SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9250742 ↗