BEUDAMED
    FDA Adverse Event Death Summary report: N

    CRURASOFT PATCH

    MDR report key: 2537636 · Received April 5, 2012

    Report

    Report Number
    1213643-2012-00249
    Event Type
    Death
    Date Received
    April 5, 2012
    Date of Event
    March 3, 2010
    Report Date
    March 8, 2012
    Manufacturer
    DAVOL INC.
    Product Code
    FTL
    PMA / PMN Number
    K022350
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CONTACTED THE INITIAL REPORT TO REQUEST ADDITIONAL INFORMATION AND TO REQUEST RETURN OF THE DEVICE FOR EVALUATION. THIS MDR INCLUDES ALL PATIENT, EVENT AND DEVICE INFORMATION DAVOL HAS RECEIVED TO DATE. BASED ON THE INFORMATION PROVIDED, IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE ATTORNEY ALLEGES THE PATIENT EXPERIENCED SEVERAL COMPLICATIONS FOLLOWING THE IMPLANT OF THE CRURASOFT PATCH AND SUBSEQUENTLY RESULTING IN THE PATIENT'S DEATH. CURRENTLY, MEDICAL RECORDS, AUTOPSY REPORT, AND/OR A DEATH CERTIFICATE HAVE NOT BEEN PROVIDED ALTHOUGH REQUESTED SEVERAL TIMES. THE INFORMATION PROVIDED INDICATES THAT THE PATIENT DEVELOPED AND WAS TREATED FOR AN INFECTION. THE WARNING SECTION OF THE IFU STATES "IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. THE PROSTHESIS MAY NOT HAVE TO BE REMOVED. AN UNRESOLVED INFECTION, HOWEVER, MAY REQUIRE REMOVAL OF THE PROSTHESIS." A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED INCLUDING A REVIEW OF STERILITY RECORDS AND THERE WAS NO EVIDENCE OF A MANUFACTURING RELATED CAUSE FOR THE REPORTED EVENT. ADDITIONALLY, NO SAMPLE WAS RETURNED FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF/WHEN ADDITIONAL INFORMATION IS PROVIDED. WITH THE CURRENTLY AVAILABLE INFORMATION, NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    THE FOLLOWING IS REPORTED BY THE PATIENT'S ATTORNEY: (IN SUMMARY) ON (B)(6) 2008 - OT UNDERWENT LAPAROSCOPIC REPAIR OF PARAESOPHAGEAL HERNIA WITH BARD CRURASOFT PATCH. REPAIR CONSISTED OF PATCH CLOSURE OF THE ESOPHAGEAL HIATUS, GASTROPLEXY AND PARTIAL FUNDOPLICATION. ON (B)(6) 2008 - PATIENT WAS SEEN FOR HEARTBURN AND "ALMOST REGURGITATION." "TIGHT WRAP" WAS SUGGESTED. PT WAS ALSO EXPERIENCING BILE REFLUX AND SUFFERING FROM MARKED DYSPHASIA. ON (B)(6) 2008 - PT'S WEIGHT DROPPED TO (B)(6), FROM PRE-SURGERY OF (B)(6). UNABLE TO TOLERATE SOLID FOODS AND LIQUIDS. MD, DURING HIS EVALUATION OF THE PT, DESCRIBED HER AS "EXTREMELY CACHECTIC". ON (B)(6) 2009 - PT'S WEIGHT HAD DROPPED TO (B)(6). PT WAS ADMITTED TO THE HOSPITAL WITH A DIAGNOSIS OF FAILURE TO THRIVE. ON (B)(6) 2009 - PT UNDERWENT EXPLORATORY LAPAROTOMY, LYSIS OF ADHESIONS, REMOVAL OF INFECTED MESH, ESOPHAGOGASTRECTOMY WITH PRIMARY ANASTOMOSIS, AND FEEDING TUBE PLACEMENT. POST-OP DIAGNOSIS, INFECTED DIAPHRAGMATIC MESH, RECURRENT PARAESOPHAGEAL HERNIA, AND SLIPPED PARTIAL FUNDOPLICATION. STOMACH WAS FREED FROM DIAPHRAGM, WHITE MATERIAL FOUND, WHICH EVIDENTLY HAD FOOD PARTICLES IN IT; DIRECT COMMUNICATION WITH MESH. SIGNIFICANT STRICTURE RIGHT AT THE GE JUNCTION AND DID NOT APPEAR TO BE RELATED TO A TOO TIGHT WRAP BUT APPEARED TO BE INTRINSIC TO ESOPHAGUS AND MAY HAVE BEEN RELATED TO INFLAMMATION RELATED TO INFECTED MESH. DUE TO EXTENSIVENESS OF INFLAMMATION AT GE JUNCTION, AN EXTENDED ESOPHAGOPLASTY WAS PERFORMED. ON (B)(6) 2010 - PT UNDERWENT SURGERY FOR STAGE IV SACRAL DECUBITUS. THE SURGEON FOUND A LARGE GROSSLY INFECTED CAVITY. ON (B)(6) 2010 - THE PT' S HEALTH CONTINUED TO DECLINE, AND SHE EXPIRED. ATTORNEY ALLEGES PT SUFFERED SERIOUS BODILY INJURIES ULTIMATELY LEADING TO HER DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRURASOFT PATCH FTL DAVOL INC. NA HURI1035

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Death| H| R