MAUDE Adverse Event Report: COVIDIEN, FORMERLY TISSUE SCIENCE LABOR PERMACOL 15X20 1MM; MESH, SURGICAL, POLYMERIC

Model Number 5152-100

Device Problems Material Rupture (1546); Torn Material (3024)

Patient Problems Failure of Implant (1924); Hernia (2240)

Event Date 01/30/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, the patient had the device implanted in an open incisional hernia repair on (b)(6) 2016.When the patient sat up in bed, the patient felt a 'pop'.The patient underwent a reoperation on (b)(6) 2016 in order to determine what had happened.During the reoperation, the device appeared to have at least 4 shreds down one side.It was removed and replaced with a different mesh product.

Manufacturer Narrative

(b)(4) a visual examination of the returned device revealed the following: the sample was not returned in its original packaging; the mesh had been cut prior to insertion making it not possible to fully match the device dimensions to those that were reported; the mesh was torn in the fibrous direction and different colors were visible at various locations on the mesh (dark white, black (mold) and red); the texture was found to be flexible where the mesh was white and dry in the dark locations; and the sample seemed to be correctly cross-linked.Remains of the suture points were observed.Most of them were the origin of the tears.It has been determined that excessive tension may have induced tearing, beginning from the holes made by the suture points.Based on the instructions for use (ifu) that accompany the device, adequate overlap is recommended to ensure sufficient margins for incorporation.Due to the dimensions of the original device prior to being cut and the dimensions of the defect, there may not have been sufficient overlap.It is also indicated in the ifu that, if this surgical implant is shaped too small for the defect, excessive tension may be placed on the sutures and possibly result in recurrence of the original tissue defect or development of a defect in the adjacent tissues.A review of the device history record (dhr) could not be performed as the lot number of the device was not made available.Should additional information be received, the record will be re-evaluated and amended as needed.Corrected data: patient code(s) and device code(s).

Event Description

Additional information received indicated that there were at least four shreds observed during the reoperation.The mesh had not been cut prior to implantation.The surgical site was not contaminated.The wound was closed after the procedure with skin staples and two subcutaneous drains.The device was sutured into the underside of the anterior abdominal wall with interrupted nylon sutures at approximately 12 fixation points.The hernia was approximately 10cm wide and 15cm long with an overlap of the device by about 3-4cm.During the reoperation, a larger overlap was placed with the new device.Two pieces of mesh were placed, one on the underside of the anterior wall and the other on the ventral wall.

• Brand Name: PERMACOL 15X20 1MM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): COVIDIEN, FORMERLY TISSUE SCIENCE LABOR; victoria house, victoria road; aldershot, hampshire ; UK
• Manufacturer (Section G): COVIDIEN, FORMERLY TISSUE SCIENCE LABOR; victoria house, victoria road; aldershot, hampshire ; UK
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 5457926
• MDR Text Key: 38964561
• Report Number: 9617613-2016-00001
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K992556
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5152-100
• Device Catalogue Number: 5152-100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 49 YR