BEUDAMED
    FDA Adverse Event Death Summary report: N

    ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM

    MDR report key: 3033232 · Received April 3, 2013

    Report

    Report Number
    2024168-2013-01944
    Event Type
    Death
    Date Received
    April 3, 2013
    Date of Event
    March 9, 2013
    Report Date
    March 9, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THOUGH THE DEVICE 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). EVALUATION SUMMARY: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS; HOWEVER, THIS INCIDENT CONTAINED PATIENT EFFECTS WITH NO ALLEGATION OF A DEVICE ISSUE AND, AS SUCH, IS NOT ON ITS OWN AN INDICATION OF A PRODUCT DEFICIENCY. ADDITIONALLY, VISUAL ANALYSIS WAS PERFORMED FOR THE RETURNED DEVICE AND 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. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF CARDIAC ARREST, DEATH, OCCLUSION, VENTRICULAR TACHYCARDIA AND CARDIOGENIC SHOCK, AS LISTED IN THE INSTRUCTIONS FOR USE, ARE KNOWN PATIENT EFFECTS THAT MAY BE ASSOCIATED WITH THE USE OF A CORONARY DEVICES IN NATIVE CORONARY ARTERIES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS 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 AND THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO A TREAT A PATIENT WHO PRESENTED WITH CHEST PAIN AND AN ST ELEVATION MYOCARDIAL INFARCTION. THE PATIENT HAD PREVIOUS CORONARY BYPASS SURGERY (2008) IN THE LEFT ANTERIOR DESCENDING (LAD) AND RIGHT CORONARY ARTERY. ANGIOGRAPHY REVEALED AN 80% STENOSED LESION IN THE OSTIAL LAD WITH NO CALCIFICATION AND MILD TORTUOSITY. USING A FEMORAL APPROACH, PRE-DILATATION WAS PERFORMED WITH A 2.5 X 10 MM NON-ABBOTT NON-COMPLIANT BALLOON. THE MOMENT THE 3.5 X 12 MM DEVICE WAS INTRODUCED, THE PATIENT DEVELOPED VENTRICULAR TACHYCARDIA. THE DEVICE WAS IMMEDIATELY REMOVED FROM THE PATIENT AND ATTEMPTS WERE MADE TO STABILIZE THE PATIENT; HOWEVER, THE PATIENT HAD A CARDIAC ARREST AND DIED ON THE TABLE. CAUSE OF DEATH WAS CARDIOGENIC SHOCK. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    CINE REVIEW OF THE PROCEDURE SHOWED ALMOST NO FLOW IN THE LEFT ANTERIOR DESCENDING ARTERY AND DIMINSHED FLOW IN THE CIRCUMFLEX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136498 ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2100261

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death