BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM

    MDR report key: 2862118 · Received December 7, 2012

    Report

    Report Number
    2024168-2012-07731
    Event Type
    Injury
    Date Received
    December 7, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 15, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. THE CUSTOMER REPORTED THE SCAFFOLD REMAINS IN THE PATIENT. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF DISSECTION, AS LISTED IN THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD (BVS) INSTRUCTIONS FOR USE, IS A KNOWN ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 1

    THE PROCEDURE WAS TO TREAT A NON-TORTUOUS, 80% STENOSED LESION IN THE MID CIRCUMFLEX ARTERY. THE LESION WAS PRE-DILATED WITH A NON-ABBOTT 2.5X12 MM BALLOON CATHETER AT 16 ATMOSPHERES (ATM). AN ABSORB 3.5X18 MM SCAFFOLD WAS THEN DEPLOYED AT 16 ATM. OPTICAL COHERENCE TOMOGRAPHY (OCT) WAS THEN USED TO EVALUATE THE ABSORB SCAFFOLD AND ALTHOUGH NOTHING WAS SEEN ON THE ANGIOGRAPHY SCREEN, IT WAS NOTICED THAT THERE WAS A SLIGHT DISSECTION DISTAL TO THE ABSORB SCAFFOLD. THE PHYSICIAN FELT THIS WAS POSSIBLY CAUSED BY THE DELIVERY BALLOON CATHETER. THE ABSORB SCAFFOLD WAS THEN POST-DILATED WITH A NC TREK 3.75X12 MM AT 26 ATM WHICH COMPLETED THE PROCEDURE. OCT WAS THEN USED AGAIN TO CHECK APPOSITION OF THE DEPLOYED ABSORB SCAFFOLD. THE PHYSICIAN WAS HAPPY WITH THE RESULT AND THE CASE WAS FINISHED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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 2071361

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention