MAUDE Adverse Event Report: SOFRADIM PRODUCTION PARIETEX PCOX THR 37X28CM X1; MESH, SURGICAL, POLYMERIC

Model Number PCO3728X

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Death (1802); Unspecified Infection (1930); Blood Loss (2597)

Event Type  Death  

Event Description

The patient came to the hospital with an obstructed incisional hernia.Patient presented with chest with crepitation, lower segment atelactasis.After a conservative measure in icu, the patient was operated.There was a huge multilocular incisional hernia at kocher incision for open cholecystectomy that was performed approximately 15 years ago.There was complete hemostasis and it was checked for mucosal tear.Only the serosal tear was sutured with vicryl 3.0.Dissection and adhesiolysis of the small bowel was performed to transverse colon, ascending caecum, omental adhesiolysis.The defect size was 15cm x 20cm.There was no bowel discoloration or constricting ring that needed further management.The mesh was fixated to the defect, so that the edge of the mesh was beyond the edge of the defect with approximately 5cm overlap.There was no evidence of increases of intra-abdominal pressure on capnogram.The mesh was not tightened around the bowel.The patient was in the icu on a ventilator for 24 hours and then was removed from ventilator.The patient was passing gases and stool 48 hours after the operation.On the 3rd day postoperative, due to a bad chest infection the patient was again on a ventilator.The patient was weaned again.Due to bad chest infection, she was on ventilator, suction of secretions.On the 7th day postoperative there was a now offensive, brownish discharge, behind the flank flap mid portion of the wound.It was washed with normal saline and nothing was seen to claim any fecal matter.On the 8th day postoperative by 5pm, there was frank intestinal fluid coming through the wound.An urgent exploratory laparotomy revealed intestinal fluid under both flaps.There was a small hole at (adherent to) the summit of the mesh and there was a small portion ½ -1cm other bowel, omentum that was not affected.Due to adherence of the bowel to the edge of the defect there was no intra-abdominal soiling.There was a resection of that part, ileostomy, mucous fistula.Again the patient was good.There was no other perforation.The suture at the serosal tear was intact.The patient was in the icy again where he was on cardiac support for one week.Then the patient developed irreversible sirs.The patient died on (b)(6) 2016.There were complications due to perforation of the small bowel.There was unanticipated blood loss of over 500ccs due to the complication.There was an extension of 4 hours and a 2nd operation.

Manufacturer Narrative

Reference number: (b)(4).No sample and no picture were provided for investigation.Without the sample a detailed investigation could not be performed.A review of the device history record has been performed.This review confirmed that this lot of products was reviewed and released results were within specifications limits for the concerned period.It should be noted that the patient clinical history is complex.The reported infection and fistula are known potential complications of this type of surgery.The product instructions for use (ifu), which accompanies each device, states that: "the possible complications associated with the use of parietex optimized composite mesh are those typically associated with surgically implantable materials: seroma/ hematoma / recurrence / adhesions/ chronic pains/ infection / fistula formation / inflammation/ allergic reactions to the components of the product." it should be also noted that the product ifu states that: "any foreign material may potentiate or prolong infection in the presence of bacterial contamination, and as such, the use of parietex optimized composite mesh may not be appropriate in infected or contaminated sites." based on our investigation and a complaint history review, the manufacture of the device is not suspected.There is no indication that there is a defective lot or that this event represents an emerging adverse quality trend.No immediate action required.The report has been added to our product complaints database which is monitored for similar occurrences.

• Brand Name: PARIETEX PCOX THR 37X28CM X1
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux ; FR
• Manufacturer (Section G): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux ; FR
• Manufacturer Contact: sharon murphy ; 60 middletown avenue; north haven, CT 06473 ; 2034925267
• MDR Report Key: 5964626
• MDR Text Key: 55203973
• Report Number: 9615742-2016-00120
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K110815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: PCO3728X
• Device Catalogue Number: PCO3728X
• Device Lot Number: P0B0586X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 69 YR