MAUDE Adverse Event Report: ETHICON INC. PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT; SUTURE, SURGICAL, ABSORBABLE

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Seroma (2069); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is related to a journal article, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.No specific patient information regarding events has 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 ethicon products involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products used in this procedure? citation: hernia.2015; 19: 267 271.Doi: 10.1007/s10029-014-1262-4.(b)(4).

Event Description

It was reported via journal article: "title: a comparative study of sutured versus bovine pericardium mesh abdominal closure after open abdominal aortic aneurysm repair" authors: c.Bali, j.Papakostas, g.Georgiou, g.Kouvelos, s.Avgos, e.Arnaoutoglou, g.Papadopoulos, m.Matsagkas citation: hernia.2015; 19: 267 271.Doi: 10.1007/s10029-014-1262-4 open abdominal aortic aneurysm (aaa) repair is followed by a high rate of incisional herniation.The purpose of this prospective randomized clinical study was to evaluate whether this post-operative complication could be avoided by a prophylactic implantation of a biological mesh.A total of 40 patients underwent open aaa and were included in the study.Of which, 20 patients were randomized under the suture fascia closure group (group a) and 20 patients were randomized under suture fascia closure reinforcement by an onlay mesh implantation.In the suture fascia closure group, after the aneurysm sac and posterior peritoneum was closed, a routine mass closure in a running 4:1 ratio pds 1-0 loop suture was made.Post-operative complication included seroma (n-1) which was treated with percutaneous drainage.It was concluded that the bovine pericardium mesh reinforcement of fascia closure in patients undergoing open aaa repair showed effectiveness and low complication rate in prophylaxis from incisional herniation.

• Brand Name: PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7475274
• MDR Text Key: 106973378
• Report Number: 2210968-2018-72479
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/23/2018

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/23/2018
• Initial Date FDA Received: 05/01/2018
• 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): Required Intervention