BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERI-STRIPS DRY WITH VERITAS COLLAGEN MATRIX (LINEAR CONFIGURATION ULTRA THIN)

    MDR report key: 3120302 · Received May 20, 2013

    Report

    Report Number
    2032282-2013-00055
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 24, 2013
    Report Date
    May 20, 2013
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    FTM
    PMA / PMN Number
    K041669
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE ATTEMPTS WERE MADE TO ACQUIRE ADDITIONAL INFORMATION THAT WOULD ALLOW FOR A MEDICAL ASSESSMENT. NO RESPONSE WAS RECEIVED. DUE TO THE LACK OF INFORMATION, A CAUSAL RELATIONSHIP CANNOT BE DETERMINED. BAXTER MEDICAL ASSESSMENT SUMMARY: NONE OF THE INFORMATION REQUESTED HAS BEEN OBTAINED; THEREFORE A CAUSALITY ASSESSMENT CANNOT BE DONE TO RULE OUT A CONTRIBUTION OF THE PERI-STRIPS DRY. CONSERVATIVELY THE USE OF PERI-STRIPS DRY MAY HAVE CAUSED OR CONTRIBUTED TO THE POSTOPERATIVE LEAK. BAXTER SYNOVIS COMPLETED THE INVESTIGATION. NO LOT NUMBER OR SAMPLE WAS AVAILABLE; THEREFORE NO BATCH REVIEW OR SAMPLE EVALUATION WAS POSSIBLE. NO TREND WAS IDENTIFIED. PER SYNOVIS, BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, THE ROOT CAUSE CANNOT BE DETERMINED AND NO FURTHER INVESTIGATION IS WARRANTED. A FINAL EMAIL WAS SENT TO THE REPORTING PHYSICIAN NOTIFYING HIM AGAIN OF THE QUESTIONS THAT REQUIRE ATTENTION AND OF CLOSURE. THE COMPLAINT WILL BE KEPT ON RECORD FOR TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS RECEIVED FROM THE REPORTING SURGEON ON (B)(4) 2013. FOLLOW-UP MEDICAL ASSESSMENT: THE ADDITIONAL CLINICAL INFORMATION RECEIVED DOES NOT ALLOW TO EXCLUDE THAT PERI-STRIPS DRY MAY HAVE CAUSED OR CONTRIBUTED TO THE POSTOPERATIVE LEAK. THE INITIAL INVESTIGATION DID NOT CHANGE BASED ON THE ADDITIONAL INFORMATION. THE COMPLAINT WILL BE KEPT ON RECORD FOR TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    (B)(4). DUE TO THE LACK OF INFORMATION, THE CASE IS NOT CURRENTLY ASSESSABLE AND THIS CASE IS BEING CONSERVATIVELY REPORTED. BAXTER IS CURRENTLY IN THE PROCESS OF FOLLOWING UP WITH THE REPORTER FOR ADDITIONAL INFORMATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON RECEIPT AND EVALUATION OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013: PATIENT INITIALS: (B)(6); AGE: (B)(6); BMI: (B)(6). DATE OF PSD IMPLANTATION: (B)(6) 2013. NUMBER OF PSD IMPLANTED: 8 GREENS WITH VERITAS SO IT WAS LONG BECAUSE STOMACH WAS CHRONICALLY DILATED. POST OP SWALLOW NEGATIVE. SURGICAL PROCEDURE AND DESCRIPTION OF WHERE PSD WERE USED: WHOLE STOMACH CHRONICALLY DILATED AT SURGERY. DATE OF LEAKAGE DIAGNOSIS: LEAK (B)(6) 2013. HOW WAS THE LEAK TREATED? TREATED WITH STENTS, ON 2ND SET OF STENTS NOW. HAD TROUBLE GETTING FIRST STENTS TO OCCLUDE THE LEAK SO HAS HAD 4 STENTING PROCEDURES. THIS IS ONGOING. PATIENT RELATED RISK FACTORS WHICH MAY HAVE CONTRIBUTED TO LEAKAGE? NOT PROVIDED. CUSTOMER ALSO PROVIDED THE FOLLOWING: I AM USING SEAMGUARD NOW (NO I AM NOT BLAMING PRODUCT BUT WITH RUN LIKE THIS I NEEDED TO CHANGE THINGS UP. I HAD NO LEAKS IN ANY PRIOR CASE >300). I AM USING 2 GREEN, 2 GOLD, 2 BLUE ALSO WHICH I USED TO DO. I SWITCHED TO ALL GREENS BASED ON RECS OF A PANEL AT SAGES LAST YEAR THAT STATED THAT USING REINFORCEMENT MEANS YOU SHOULD USE ALL GREENS TAKING INTO ACCOUNT STAPLE HEIGHT. I HAD NO LEAKS WITH 2/2/2 PRIOR TO THAT.

    Description of Event or Problem · 1

    A PHYSICIAN REPORT TO BAXTER THAT 3 LEAKS OCCURRED OVER 6 MONTHS WHEN USING PERI STRIPS DRY. THIS IS ONE OF THREE REPORTS. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221737 PERI-STRIPS DRY WITH VERITAS COLLAGEN MATRIX (LINEAR CONFIGURATION ULTRA THIN) MESH, SURGICAL FTM SYNOVIS SURGICAL INNOVATIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR