BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASCU-GUARD PERIPHERAL VASCULAR PATCH WITH APEX PROCESSING

    MDR report key: 3092646 · Received May 3, 2013

    Report

    Report Number
    2032282-2013-00049
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 19, 2013
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    DXZ
    PMA / PMN Number
    K983602
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER SYNOVIS COMPLETED THE INVESTIGATION. SAMPLE EVALUATION AND BATCH REVIEW COULD NOT BE PERFORMED AS NO SAMPLE OR LOT NUMBER WAS PROVIDED. PER SYNOVIS, STENOSIS AT THE SITE OF THE PERICARDIAL PATCH RING IS A KNOWN COMPLICATION OF THIS TYPE OF PROCEDURE AS CITED IN THE ARTICLE "HISTORICALLY, 3% TO 20% OF RYGB PATIENTS REQUIRE ENDOSCOPIC MANAGEMENTS." THE OCCURRENCE IN THIS STUDY SHOWED 1.2% OF THE PATIENTS USING THE VASCU-GUARD PATCH REQUIRED BALLOON DILATION TO RELIEVE THE SYMPTOMS, BELOW THE HISTORICAL RATE. THE PATCH WAS USED IN A PROCEDURE NOT INCLUDED WITHIN THE VASCU-GUARD INSTRUCTIONS FOR USE. THE MANUFACTURING FACILITY DETERMINED NO FURTHER INVESTIGATION IS REQUIRED AS THIS IS A KNOWN COMPLICATION OF PROCEDURE AND THE EVENT FALLS WITHIN ACCEPTABLE RISK PARAMETERS. THE CASE WILL BE KEPT ON FILE FOR TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT SUMMARY: A ROUX-EN-Y GASTRIC BYPASS, IN WHICH A 0.8 X 8 CM VASCU-GUARD PERICARDIAL PATCH HAS BEEN USED TO CREATE A RING PROXIMAL TO THE GASTROJEJUNOSTOMY CREATING A 7.0 CM CIRCUMFERENCE RING. AT AN UNSPECIFIED POSTOPERATIVE TIME INTERVAL, AN OUTPATIENT UPPER ENDOSCOPY WITH BALLOON DILATATION HAS BEEN PERFORMED. TWO PATIENTS IN THE PUBLISHED SERIES HAD A STENOSIS AT THE SITE OF THE APPLIED VASCU-GUARD. GIVEN THE STENOSIS SITE, THE COMPLICATION MAY BE RELATED TO THE USE OF THE BIOLOGIC IMPLANT (VASCU-GUARD). THE BALLOON DILATATION LED TO FULL RECOVERY OF THE PATIENT. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT AND EVALUATION OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    FROM LITERATURE: MOON R, TEIXEIRA A, JAWAD MA (2013). PERICARDIAL PATCH RING ROUX-EN-Y GASTRIC BYPASS: A PRELIMINARY REPORT. OBES SURG. 2013 APR;23(4):480-5. DOI: 10.1007/S11695-012-0838-2. SUMMARY OF ARTICLE FROM ABSTRACT: BETWEEN MARCH 2010 AND JUNE 2011, A TOTAL OF 189 PATIENTS UNDERWENT PERICARDIAL PATCH RING RYGB AT THE BARIATRIC AND LAPAROSCOPY CENTER. A RETROSPECTIVE REVIEW OF A PROSPECTIVELY COLLECTED DATABASE WAS PERFORMED FOR ALL PERICARDIAL PATCH RING RYGB PATIENTS, NOTING THE OUTCOMES AND COMPLICATIONS OF THE PROCEDURE. PERICARDIAL PATCH RING RYGB PATIENTS DEMONSTRATED A MEAN PERCENTAGE OF EXCESS WEIGHT LOSS OF 57.4% AT A MEAN FOLLOW-UP OF 11 MONTHS. OUT OF 164 PATIENTS WITH FOLLOW-UP, FIVE (3.0 %) PATIENTS REQUIRED ENDOSCOPIC BALLOON DILATION DUE TO DYSPHAGIA, ABDOMINAL PAIN, AND/OR GASTRIC OUTLET OBSTRUCTION. ALL PATIENTS DID WELL AFTER THE PROCEDURE. THREE (1.8 %) PATIENTS UNDERWENT DIAGNOSTIC LAPAROSCOPY FOR ABDOMINAL PAIN. OF THESE PATIENTS, ONE (0.6 %) HAD DILATED AND ENLARGED BLIND LIMB, AND TWO (1.2 %) PATIENTS HAD PARTIAL SMALL BOWEL OBSTRUCTION. NO PATIENT WAS RE-ADMITTED OR RE-OPERATED DUE TO PERICARDIAL PATCH RING. (SEE ATTACHED FOR FULL ARTICLE.) THE LOT NUMBER(S) AND PRODUCT CODE(S) ARE UNKNOWN. A RANDOM PRODUCT CODE WAS SELECTED FOR THE PURPOSE OF OPENING THIS COMPLAINT. STENOSIS PATIENT 2: UPON REVIEW OF THE ARTICLE, IT WAS IDENTIFIED TWO PATIENTS EXPERIENCED STENOSIS. THIS IS ONE OF TWO REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194257 VASCU-GUARD PERIPHERAL VASCULAR PATCH WITH APEX PROCESSING PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE DXZ SYNOVIS SURGICAL INNOVATIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other