BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM

    MDR report key: 3033843 · Received April 3, 2013

    Report

    Report Number
    2024168-2013-01953
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED DIFFICULTY REMOVING THE PROTECTIVE SHEATH COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS THE PROTECTIVE SHEATHS WERE NOT RETURNED. THE REPORTED BALLOON RUPTURE WAS NOT CONFIRMED; HOWEVER, A PROXIMAL SEAL SEPARATION WAS CONFIRMED. BASED ON THE VISUAL, DIMENSIONAL AND FUNCTIONAL 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. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. CONCOMITANT MEDICAL DEVICES: GUIDE WIRE: BALANCE MIDDLEWEIGHT; GUIDE CATH: EBU 3.5 6FR. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL 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.

    Description of Event or Problem · 1

    THE PROCEDURE WAS TO TREAT THE MID-TO-DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY THAT DID NOT HAVE ANY CALCIFICATION. PRE-DILATATION WAS PERFORMED WITH A TREK 2.5 BALLOON CATHETER. THE 2.5X18 MM IMPLANT WAS SUCCESSFULLY PLACED AT THE TARGET LESION WITH NO RESISTANCE FELT. AT THE MOMENT OF INFLATING THE BALLOON WITH AN INDEFLATOR 20/30, UNDER FLUOROSCOPY IT WAS NOTICED THAT THE CONTRAST EXITED FROM THE BALLOON IN THE CORONARY WITHOUT ANY SIGN OF INFLATION. THE DEVICE WAS REMOVED FROM THE PATIENT'S ANATOMY AND THE PROCEDURE WAS CONCLUDED WITH SUCCESS BY USING ANOTHER 2.5X18 MM IMPLANT. THE PHYSICIAN STATED THAT HE EXPERIENCED SOME FRICTION DURING THE PROTECTIVE SHEATH REMOVAL BEFORE USE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136217 ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2101562

    Patients

    Seq Age Sex Outcome Treatment
    1