MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH; MESH, SURGICAL, POLYMERIC

Model Number	PCO3020FX
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fistula (1862); Injury (2348)
Date of Event	02/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, this was a hernia procedure midline ovhr.The mesh migrated and rolled up into small bowel, this part had to be removed.The patient presented with an enterocutaneous fistula.Supplementary intervention was needed due to the enterocutaneous fistula.A end-to-end anastomoses was performed with standard surgical procedure for partial removal of the affected small bowel, removal of the enterocutaneous fistula with the rolled up mesh.The surgical time was extended 30 minutes or more due to removal of rolled up mesh.The incision was extended more than one inch.The wound was closed with sutures and standard abdominal wall closure.The patient outcome is alive with injury.The specimen was collected an sent to pathology (b)(6) to clarify if there are pathological changes of the small bowel.There will be an additional operation to correct the issue.The mesh was implanted (b)(6) 2015 and partial explant (b)(6) 2018 (28.1 months).
Additional Manufacturer Narrative
Evaluation summary: a review of the device history record has been performed and no failure has been found that may relate to the reported conditions have been noted.The visual examination of the provided pictures shows that the mesh was rolled up into the small bowel.It should be noted that there is no information regarding the first surgery have been found.The product ifu (instructions for use) which accompanies each device states in chapter ¿possible complications¿ that: the possible complications associated with the use of device optimized composite mesh are those typically associated with surgically implantable materials: seroma/ hematoma/recurrence/adhesions/chronic pains/infection/fistula formation/irritation/inflammation/ allergic reactions to the components of the product.The report has been added to our product complaints database which is monitored for similar occurrences.There is no indication that there is a defective lot or that this event represents an emerging adverse quality trend.Although a specific root cause analysis could not be performed, the incident is maintained in our database for a broader trend analysis.If additional information is obtained, or the sample is returned, we will re-open this investigation.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: MESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 7388581
• Report Number: 9615742-2018-00636
• Device Sequence Number: 238794
• Product Code: FTL
• UDI-Device Identifier: 10884521179844
• UDI-Public: 10884521179844
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K110663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/19/2018

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: 06/30/2019
• Device Model Number: PCO3020FX
• Device Catalogue Number: PCO3020FX
• Device Lot Number: POF0514X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2018
• Initial Date Received by Manufacturer: 03/06/2018
• Supplement Date Received by Manufacturer: 04/10/2018; 06/01/2018
• Initial Report FDA Received Date: 04/02/2018
• Supplement Report FDA Received Date: 04/26/2018; 06/19/2018
• 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: Other; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 112