MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS SYMBOTEX; MESH, SURGICAL, POLYMERIC

Model Number	SYM3728
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Torn Material (3024)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According the reporter: the patient underwent a laparoscopic recurrent incisional ventral hernia repair.Four days post op, the patient underwent an exploratory laparotomy to remove the graft which lead to extended hospitalization and caused temporary injury to the patient.The surgeon described the mesh as "faulty." the current patient status is inpatient icu.An additional operation will be performed to correct the issue.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According the reporter: as per the additional information received, the surgeon described the sutures tore from the mesh, it was defective and the product dislodged.Actual mesh ripped on the left edge with 3 or 4 holes.Mesh was hydrated before putting it in.Patient was taken back old mesh removed and new mesh put in.Sutured fixation system was used.Patient is doing fine now.Patient medical history: obese patient with large ventral hernia and loss of domain.
Additional Manufacturer Narrative
Evaluation summary: the visual examination of the returned sample shows that: the sample was not returned in its original packaging.It was placed in a biohazard bag and the mesh was found contaminated by blood.The mesh was found cut, mesh dimension around 25x24 instead of 37x28 initially.The textile knitting was found as expected however the collagen seems to be partially reduced.Four holes of different sizes are visible: - hole n°1: defect length 3 cm, defect width 2 stitches - hole n°2: defect length 2 cm, defect width 3 stitches - hole n°3: defect length 12 cm, defect width 5 cm - hole n°4: defect length 1 cm, defect width 3 stitches conclusion of the visual examination determined that excessive tension is highly suspected.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SYMBOTEX
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 6873655
• Report Number: 9615742-2017-05261
• Device Sequence Number: 820064
• Product Code: FTL
• UDI-Device Identifier: 10884521190566
• UDI-Public: 10884521190566
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K131969
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: SYM3728
• Device Catalogue Number: SYM3728
• Device Lot Number: PPL0799X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2018
• Initial Date Received by Manufacturer: 08/15/2017
• Supplement Date Received by Manufacturer: 10/17/2017; 02/16/2018
• Initial Report FDA Received Date: 09/18/2017
• Supplement Report FDA Received Date: 11/06/2017; 03/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 56 YR