BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM

    MDR report key: 6004941 · Received October 6, 2016

    Report

    Report Number
    2024168-2016-06725
    Event Type
    Injury
    Date Received
    October 6, 2016
    Date of Event
    August 30, 2016
    Report Date
    November 29, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    PNY
    PMA / PMN Number
    P150023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SCAFFOLD REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE U.S.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THREE ABSORB SCAFFOLDS WERE REPORTED AND IT IS UNKNOWN WHICH ONE HAD THE REPORTED ISSUE, THE LOT HISTORY RECORD REVIEW WAS PERFORMED FOR ALL THREE DEVICES. ABSORB 3.0 X 12 MM (PART 1012463-12, LOT 406196A); MANUFACTURING DATE: 19-JUNE-2014; EXPIRATION DATE: 15-DECEMBER-2015; (B)(4). ABSORB 3.5 X 18 MM (PART 1012464-18, LOT 4080861); MANUFACTURING DATE: 08-AUGUST-2014; EXPIRATION DATE: 07-AUGUST-2015; (B)(4). ABSORB 3.5 X 28 MM (PART 1012464-28, LOT 4080561): MANUFACTURING DATE: 05-AUGUST-2014; EXPIRATION DATE: 04-AUGUST-2015; (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE REPORTED PATIENT EFFECTS OF ANGINA AND THROMBOSIS, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE (IFU), ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS; HOWEVER THE REPORTED SCAFFOLD DISCONTINUITIES APPEAR TO BE DUE TO CIRCUMSTANCES OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ELECTIVE PROCEDURE ON (B)(6) 2015 WAS TO TREAT AN UNSPECIFIED CORONARY ARTERY. PRE-DILATATION WAS PERFORMED, REDUCING THE STENOSIS TO LESS THAN 40%. THREE ABSORB SCAFFOLDS (3.0 X 12 MM, 3.5 X 28 MM (X2)) WERE IMPLANTED. IT IS UNKNOWN IF POST-DILATATION WAS PERFORMED. OPTICAL COHERENCE TOMOGRAPHY (OCT) WAS USED AND CONFIRMED THAT THE SCAFFOLD PLACEMENT LOOKED GREAT. THE PATIENT RETURNED 18 MONTHS LATER ((B)(6) 2016) WITH CHEST PAIN. AN ANGIOGRAM AND OCT WERE DONE AND IT WAS NOTED THAT ONE OF THE SCAFFOLDS HAD FRACTURED STRUTS WHICH WERE HANGING IN THE VESSEL LUMEN. THIS SAME SCAFFOLD WAS NOT COVERED BY ENDOTHELIUM WHICH CAUSED SCAFFOLD THROMBUS. A DRUG ELUTING STENT WAS USED TO OPEN THE LUMEN AND CRUSH THE HANGING SCAFFOLD STRUTS TO THE VESSEL WALL. THE OTHER TWO SCAFFOLDS LOOKED PERFECT. THE FINAL PATIENT OUTCOME WAS GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    CORRECTION: THE THREE ABSORB SCAFFOLDS IMPLANTED WERE A 3.0X12MM, 3.5X18MM AND A 3.5X28MM. IT COULD NOT BE CONFIRMED WHICH SCAFFOLD APPEARED FRACTURED AND HAD THOMBOSIS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656946 ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM BIORESORBABLE DRUG ELUTING SCAFFOLD PNY AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R ABSORB SCAFFOLDS: 3.0 X 12 MM, 3.5 X 28 MM (X2)