BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM

    MDR report key: 2880416 · Received December 19, 2012

    Report

    Report Number
    2024168-2012-08179
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    October 4, 2012
    Report Date
    October 9, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. EVALUATION SUMMARY: (B)(4) - EXCESSIVE FORCE USED IN THE REMOVAL OF THE SHEATH. THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED KINK WAS NOT CONFIRMED; HOWEVER, A SHAFT SEPARATION WAS NOTED. BASED ON THE VISUAL ANALYSIS OF THE DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT SHOULD BE NOTED THAT THE BVS INSTRUCTIONS FOR USE STATES: PRIOR TO REMOVAL OF THE PACKAGING MATERIAL, CAREFULLY SLIDE THE YELLOW OUTER SHEATH TOWARDS THE DISTAL FLARE, OPENING THE LONGITUDINAL SPLIT ON THE INNER SHEATH. REMOVE BOTH SHEATH PIECES AND STYLET FROM THE DELIVERY SYSTEM. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THIS EVENT IS BEING FILED FOR THE SHAFT SEPARATION IN THE SCAFFOLD DELIVERY SYSTEM. THOUGH THE DEVICE, ABSORB BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, IS NOT APPROVED FOR SALE IN THE U.S., IT USES A DELIVERY SYSTEM WHICH IS SIMILAR TO A DEVICE SOLD IN THE U.S. THE PRODUCT CODE LISTED IN TYPE AND THE PMA# LISTED, IS BASED ON THE XIENCE V STENT SYSTEM PREDICATE DEVICE THAT IS DETERMINED TO BE SAME AND SIMILAR TO THE DELIVERY SYSTEM OF THIS (BVS) DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER OF THE ABSORB DELIVERY SYSTEM BECAME KINKED WHEN THE PHYSICIAN PULLED TOO HARD AT THE PROTECTIVE SHEATH. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. ANOTHER BIORESORBABLE VASCULAR SCAFFOLD WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. HOWEVER, DEVICE ANALYSIS FOUND A SHAFT SEPARATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2070661

    Patients

    Seq Age Sex Outcome Treatment
    1