MAUDE Adverse Event Report: SOFRADIM PRODUCTION PCO VENTRAL PATCH 6C; MESH, SURGICAL, POLYMERIC

Model Number PCO6VP

Device Problem Obstruction of Flow (2423)

Patient Problems Pain (1994); Obstruction/Occlusion (2422)

Event Date 06/05/2014

Event Type  Injury  

Event Description

According to the reporter, nine days after the procedure, a second emergency surgery was performed to remove the device as it was attached to the small bowel creating an obstruction.The device was initially placed to repair a supra umbilical hernia.Pain from the procedure was minimal and had almost relieved completely by day six post operation.On day seven, the patient began experiencing pain and distention of the abdomen.It was reported that the patient was advised to take advil and sent home.The pain was reported to have become excruciating and the patient was admitted into the emergency department where an abdominal ct scan found a localized obstruction.A nasogastric tube was inserted in the emergency department to remove the obstructed fluids.A second ct scan showed no progress in the bowel.Surgery was performed to address the issue.During the surgery is when the mesh was found to be adhered to the small bowel.The patient was in the hospital for five days to recover.Additional information has been requested but not yet received.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Evaluation of the incident is in progress.Once complete, a supplemental will be submitted.(b)(4).

Event Description

Explant surgical notes indicated that a segment of bowel was adhered to the mesh with evidence of significant inflammation and a transition point from kinking and was carefully detached, without evidence of any further pathology.Mesenteric edema noted that was suggestive for ischemia.The obstruction, per the surgical notes, appeared to be related to two inflammatory processes, one at the level of the umbilicus and the other within a small left inguinal hernia.The explanted tissue was sent for pathology.The patient is currently well and required no further intervention.

Manufacturer Narrative

(b)(4).A review of the device history record has been performed.Overall, this review confirmed that this lot of products was released according to qa specifications.Especially, the qc records related to the manufacturing and the testing of the collagen based film ((b)(4)) show results within qa specification.No sample and no picture were provided for investigation.Without the sample a detailed investigation could not be performed.The reported visceral adhesion is a known potential complication of this type of surgery; this is a procedural related complication that is not normally attributed to any product/process deficiencies.A search in our global complaints database could not been performed as the lot number was not provided.The report has been added to our product complaints database which is monitored for similar occurrences.

Manufacturer Narrative

(b)(4).Device evaluation summary - a search of our global complaints database revealed that this was the only report on file for this lot of product.

• Brand Name: PCO VENTRAL PATCH 6C
• 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 ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 4808719
• MDR Text Key: 5920082
• Report Number: 9615742-2015-00047
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142908
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: PCO6VP
• Device Catalogue Number: PCO6VP
• Device Lot Number: PNL0186
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 99