BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 3965421 · Received July 29, 2014

    Report

    Report Number
    2032282-2014-00096
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    June 18, 2007
    Report Date
    July 17, 2014
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    FTM
    PMA / PMN Number
    K041669
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. NO TREND WAS IDENTIFIED. PER SYNOVIS, THE ROOT CAUSE FOR THE PSEUDOCYSTS IS NOT DETERMINABLE. THIS COMPLAINT WILL BE KEPT ON RECORD FOR TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT: A PUBLICATION ON DISTAL PANCREATECTOMIES DESCRIBING THE DIVISION OF PANCREAS WITH THE 60-MM ETHICON ECHELON STAPLER (ETHICON ENDO-SURGERY, (B)(4)) WITH A GREEN LOAD AND REINFORCEMENT WITH PERI-STRIP DRY WITH VERITAS (SYNOVIS, (B)(4)) HAS BEEN REVIEWED. THE TECHNIQUE OF MESH REINFORCEMENT OF THE PANCREATIC TRANSECTION LINE HAS BEEN ASSOCIATED IN THE LITERATURE WITH LOWER RATES OF CLINICALLY SIGNIFICANT PANCREATIC FISTULA. THE PUBLICATION DESCRIBES 15 COMPLICATIONS THAT OCCURRED POSTOPERATIVELY. PERI-STRIPS DRY WITH VERITAS (PSDV) IS INTENDED FOR USE AS A PROSTHESIS FOR THE SURGICAL REPAIR OF SOFT TISSUE DEFICIENCIES USING SURGICAL STAPLERS WHEN STAPLE LINE REINFORCEMENT IS NEEDED. PSD VERITAS REINFORCES THE TISSUE AND OPTIMIZE TISSUE REGENERATION (REMODELING) IN THE REPAIR AREA, BUT DOES NOT PRIMARILY SEAL THE STAPLE LINE. THE RATES OF PANCREATIC LEAKS, FISTULAS, INFECTIONS, AND OVERALL SHORT-TERM SERIOUS COMPLICATIONS REPORTED IN THE PUBLICATION ARE COMPARABLE TO THOSE PUBLISHED FOR OTHER SERIES OF LAPAROSCOPIC DISTAL PANCREATECTOMIES IN WHICH PSD VERITAS IS NOT USED. GIVEN ITS COMBINED USE WITH STAPLES, THE PRESENCE OF PANCREATIC DISEASED TISSUE, AND ADDITIONAL PATHOLOGY AND TREATMENT RELATED FACTORS THAT MAY INFLUENCE THE SURGICAL HEALING IT IS UNLIKELY THAT THE USE OF PSD VERITAS HAS CAUSED OR CONTRIBUTED TO THE POSTOPERATIVE COMPLICATION. YET BASED ON THE NATURE OF THE CLINICAL INFORMATION (FROM A RETROSPECTIVE COHORT STUDY) AND THE LACK OF SPECIFIC DETAILED CLINICAL AND PRODUCT INFORMATION (LOT NUMBERS) WE CANNOT RELIABLY EXCLUDE THAT THE USE OF PSD VERITAS HAS CONTRIBUTED TO THE REPORTED POSTOPERATIVE COMPLICATION. NON-BAXTER PRODUCT MANUFACTURERS WERE NOTIFIED OF THE LITERATURE CASE. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT AND EVALUATION OF MANUFACTURER¿S INVESTIGATION.

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED FROM A LITERATURE STUDY (WORHUNKSY, DAVID J. ET. AL. ¿LAPAROSCOPIC SPLEEN-PRESERVING DISTAL PANCREATECTOMY: THE TECHNIQUE MUST SUIT THE LESION.¿ J GASTROINTEST SURG DOI 10.1007/S11605-014-2561-X. THE SOCIETY FOR SURGERY OF THE ALIMENTARY TRACT. 18-JUN-2014). A TOTAL OF FIFTEEN (15) COMPLICATIONS WERE IDENTIFIED IN WHICH PSD VERITAS WAS USED DURING SURGERY, THE COMPLICATIONS OBSERVED ARE AS FOLLOWS: ONE (1) PATIENT HAD A FISTULA THAT REQUIRED CT-GUIDED DRAIN PLACEMENT AT 4 WEEKS POSTOPERATIVELY (ISGPF GRADE B). ONE (1) PATIENT DEVELOPED AN INTRA-ABDOMINAL INFECTION REQUIRING ICU ADMISSION FOR TRANSIENT HYPOTENSION, THOUGH WAS RESPONSIVE TO ANTIBIOTICS AND PERCUTANEOUS DRAINAGE (CLAVIEN-DINDO GRADE IV). TWO (2) PATIENTS DEVELOPED PSEUDOCYSTS (ISGPF GRADE B) AND REQUIRED CYSTGASTROSTOMY AT 3 (ENDOSCOPIC CYSTGASTROSTOMY) AND 5 MONTH S (OPEN CYSTGASTROSTOMY). ELEVEN (11) PANCREATIC LEAKS (20 %), EIGHT (8) OF WHICH WERE CONTROLLED BY SURGICAL DRAINS AND RESOLVED WITHOUT SEQUELAE (ISGPF GRADE A). THIS ONE OF FIFTEEN (15) MDRS. THIS REPORT REFLECTS ONE OF THE TWO PATIENTS WHO EXPERIENCED PSEUDOCYSTS. PATIENT 3 OF 15 (PSEUDOCYSTS): ABSTRACT: SPLENIC PRESERVATION IS CURRENTLY RECOMMENDED DURING MINIMALLY INVASIVE SURGERY FOR BENIGN TUMORS OF THE DISTAL PANCREAS. THE AIM OF THIS STUDY WAS TO EVALUATE THE OUTCOMES OF PATIENTS UNDERGOING LAPAROSCOPIC SPLEEN-PRESERVING DISTAL PANCREATECTOMY, WITH PARTICULAR ATTENTION PAID TO THE TECHNIQUE USED FOR SPLEEN PRESERVATION (SPLENIC VESSEL LIGATION VS PRESERVATION). A REVIEW OF CONSECUTIVE PATIENTS WHO UNDERWENT LAPAROSCOPIC DISTAL PANCREATECTOMY WITH THE INTENTION OF SPLENIC PRESERVATION WAS CONDUCTED. PATIENT DEMOGRAPHICS, OPERATIVE DATA, AND OUTCOMES WERE COLLECTED AND ANALYZED. FIFTY-FIVE CONSECUTIVE PATIENTS UNDERWENT LAPAROSCOPIC DISTAL PANCREATECTOMY WITH THE INTENTION OF SPLENIC PRESERVATION; 5 REQUIRED SPLENECTOMY (9 %). OF THE REMAINING 50 PATIENTS, 31 (62 %) HAD SPLENIC VESSEL LIGATION, AND 19 (38 %) HAD VESSEL PRESERVATION. PATIENT DEMOGRAPHICS AND TUMOR SIZE WERE SIMILAR. THE VESSEL LIGATION GROUP HAD SIGNIFICANTLY MORE PANCREAS REMOVED (95 VS 52 MM, P<0.001) AND LONGER OPERATIVE TIMES (256 VS 201 MIN, P=0.008). POSTOPERATIVE OUTCOMES, COMPLICATION RATES, AND SPLENIC VIABILITY WERE SIMILAR BETWEEN GROUPS. LAPAROSCOPIC SPLEEN-PRESERVING DISTAL PANCREATECTOMY IS A SAFE OPERATION WITH A HIGH RATE OF SUCCESS (91 %). VESSEL LIGATION WAS THE CHOSEN TECHNICAL STRATEGY FOR LESIONS THAT REQUIRED RESECTION OF A GREATER LENGTH OF PANCREAS. WE FOUND NO ADVANTAGE TO EITHER TECHNIQUE WITH RESPECT TO OUTCOMES AND SPLENIC PRESERVATION. OPERATIVE APPROACH SHOULD REFLECT TECHNICAL CONSIDERATIONS INCLUDING LOCATION IN THE PANCREAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442207 PERI-STRIPS DRY WITH VERITAS COLLAGEN MATRIX (LINEAR CONFIGURATION) MESH, SURGICAL FTM SYNOVIS SURGICAL INNOVATIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other