MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE SUTURE; SUTURE, NONABSORBABLE

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Hematoma (1884); Sepsis (2067); Not Applicable (3189)

Event Type  Death  

Manufacturer Narrative

(b)(4).The event was reported through a journal article.No specific patient information regarding the events have been provided and it is unknown if the events have been previously reported.No product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.Attempts are being made to obtain the following information.If further details are received at the later date a supplemental medwatch will be sent.Does the surgeon believe that the ethicon product involved caused and/or contributed to the postoperative complications described in the article? does the surgeon believe that prolene suture caused/ contributed to the patient death (retroperitoneal hematoma ¿ patient died of sepsis)? does the surgeon believe there was any deficiency with the ethicon suture product prolene used in this procedure? were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.[journal article- mizrahi 2012 (1).Pdf].

Event Description

It was reported in a journal article entitled: laparoscopic slit mesh repair of parastomal hernia using a designated mesh: long-term results authors: h.Mizrahi, p.Bhattacharya, m.C.Parker citation: surg endosc.2012; 26: 267 270.Doi: 10.1007/s00464-011-1866-z.Parastomal hernia (ph) is a frequent complication of colorectal surgery.This retrospective study was designed to assess the outcome in patients who underwent laparoscopic ph repair using a slit mesh/keyhole technique.A total of 29 laparoscopic ph mesh repairs (10 males and 19 females) were performed with an average age of 63.5 (range 42 to 81, median 64) years to treat paracolostomy hernia (n-18), para-ileostomy hernia (n-10), and for an ileal conduit site hernia (n-1).During the surgical procedure, transcutaneous buried prolene sutures were added to fix the mesh in 4 circumferential peripheral points, and 1 internal approximating suture of the slit edges of the mesh near the stoma site was placed.Reported complications includes an elderly patient with retroperitoneal hematoma necessitating a second operation, but eventually died of sepsis.It was concluded that the laparoscopic slit mesh/keyhole repair is feasible, although it is a complex surgery reflected by extended operative time.The high recurrence rate suggests that technical improvement of the method is essential.Additional information has been requested.

Manufacturer Narrative

(b)(4).It was reported that this device is not malfunction reportable.Therefore, this medwatch is not reportable.

• Brand Name: PROLENE POLYPROPYLENE SUTURE
• Type of Device: SUTURE, NONABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7605588
• MDR Text Key: 111191814
• Report Number: 2210968-2018-73498
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K133356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/23/2018
• Initial Date FDA Received: 06/15/2018
• Supplement Dates Manufacturer Received: 07/18/2018
• Supplement Dates FDA Received: 07/26/2018
• 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