BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    MDR report key: 10233624 · Received July 6, 2020

    Report

    Report Number
    2024168-2020-05478
    Event Type
    Death
    Date Received
    July 6, 2020
    Date of Event
    June 10, 2020
    Report Date
    October 8, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MAF
    UDI-DI
    08717648176463
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. IT SHOULD BE NOTED THAT THE REPORTED PATIENT EFFECTS OF SURGICAL PROCEDURE AND DEATH, AS LISTED IN THE GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM, INSTRUCTIONS FOR USE, ARE KNOWN PATIENT EFFECTS THAT MAY BE ASSOCIATED WITH USE OF A CORONARY STENT IN NATIVE CORONARY ARTERIES. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT-DEVICE INCOMPATIBILITY/DEVICE OPERATES DIFFERENTLY (FAILURE TO SEAL)/STENT GRAFT LEAK. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S), AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED; HOWEVER, THE SUBSEQUENT TREATMENTS APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING OF THE DEVICE.H6: PATIENT CODE 1888 REMOVED.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE PREVIOUS MEDWATCH REPORT, THE ADDITIONAL INFORMATION WAS RECEIVED VIA ABBOTT VASCULAR REVIEW OF CINE. AN IMPELLA DEVICE WAS PLACED FOR THE CORONARY INTERVENTION. AN ATHERECTOMY WAS PERFORMED IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WHEN A PERFORATION OCCURRED. DRUG ELUTING STENTS WERE PLACED, HOWEVER, THE BLEEDING CONTINUED AND STARTED TO BLEED INTO THE PERICARDIUM. PERICARDIOCENTESIS WAS PERFORMED AND ANOTHER DES WAS IMPLANTED IN THE PROXIMAL LAD. THE BLEEDING CONTINUED. THE LCX WAS ALSO JAILED BY THE UNSPECIFIED DES IMPLANTED IN THE LAD. FURTHER IMAGING WAS PERFORMED AND THE PERFORATION COULD HAVE BEEN A SPIRAL DISSECTION OF THE LAD. THE NON-ABBOTT COVERED STENT (PAPYRUS) WAS THEN IMPLANTED. IMAGING WAS PERFORMED AND THE 4.0X26MM GRAFTMASTER STENT (1012582-26, 9071641) WAS IMPLANTED. BALLOON ANGIOPLASTY WAS PERFORMED SEVERAL TIMES, INCLUDING IN THE LAD AND CX AS WELL AS KISSING BALLOON ATTEMPTS IN THE LAD AND CX OSTIUM. CARDIOPULMONARY RESUSCITATION (CPR) AND THEN OPEN HEART SURGERY WERE PERFORMED WITH POSSIBLE ECMO CANNULATION. PERICARDIAL PACING WIRES, SURGICALLY PLACED GRAFTS WITHIN THE CHEST WALL, AND A SWAN-GANZ CATHETER WAS PLACED. ON (B)(6)2020, THE PATIENT HAD EXPIRED DUE TO COMPLICATIONS FROM THE PERFORATION.

    Additional Manufacturer Narrative · 1

    THE STENT REMAINED IMPLANTED AND IS NOT RETURNING FOR ANALYSIS. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2020, AN ATHERECTOMY WAS PERFORMED IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WHEN A PERFORATION OCCURRED. BALLOON ANGIOPLASTY WAS PERFORMED AND DRUG-ELUTING STENTS WERE SUCCESSFULLY IMPLANTED. THE PERFORATION CONTINUED AND AS ADDITIONAL TREATMENT, A NON-ABBOTT COVERED STENT WAS IMPLANTED. THE PERFORATION CONTINUED AND A 4.0X26MM GRAFTMASTER STENT (1012582-26, 9071641) WAS SUCCESSFULLY IMPLANTED. THE PERFORATION HOWEVER, HAD NOT SEALED. THERE WAS NO DEVICE MALFUNCTION NOTED, HOWEVER, THE CAUSE OF CONTINUED BLEEDING/PERFORATION WAS UNKNOWN. REPORTEDLY, IT IS UNKNOWN IF THERE WAS ANY DEVICE LEAKING. THE PATIENT WAS TAKEN TO SURGERY AND OPEN HEART SURGICAL REPAIR WAS PERFORMED. THE BLEEDING HAD CONTINUED AND A PERICARDIOCENTESIS WAS PERFORMED. ON (B)(6) 2020, THE PATIENT EXPIRED DUE TO COMPLICATIONS FROM THE PERFORATION. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700484 GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM CORONARY STENT DELIVERY SYSTEM MAF ABBOTT VASCULAR 1012582-26 9071641 08717648176463

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death IMPELLA| PAPYRUS COVERED STENT| PAPYRUS COVERED STENT