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

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Hernia (2240); 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.Citation: british journal of surgery.2011; 98: 633 639.Doi: 10.1002/bjs.7398.(b)(4).

Event Description

It was reported via journal article: ¿title: randomized clinical trial comparing polypropylene or polydioxanone for midline abdominal wall closure¿ authors: a.Bloemen, p.Van dooren, b.F.Huizinga, a.G.M.Hoofwijk citation: british journal of surgery.2011; 98: 633 639.Doi: 10.1002/bjs.7398.This prospective randomized trial compared the suture materials for closure of the fascia after abdominal surgery.The study hypothesize that non-absorbable sutures (prolene) would result in fewer incisional hernias than slowly absorbed sutures (pds), while not causing other complications such as suture sinus or surgical-site infection.A total of 456 patients underwent an elective or emergency midline laparotomy and were included in the study.Of which, 223 patients were randomized under closure with prolene sutures and 233 patients under closure with pds sutures.The closure of the fascia of the abdominal wall was performed after surgery had been completed using one of the two suture materials (prolene 1-0 or pds 1-0 sutures) as prescribed by randomization.The fascia was closed in a single layer with wide bites through the rectus sheath (minimum 1 cm from the incision edge).The suture length to laparotomy wound length ratio was at least 4:1.Continuous sutures and two complete suture lengths were used for all wounds.In the prolene sutures group, reported complications included incisional hernia (n-45), fascial dehiscence (n-9), surgical site infection (n-14), and suture sinus (n-3).In the pds sutures group, reported complications included incisional hernia (n-58), fascial dehiscence (n-18), surgical site infection (n-18), and suture sinus (n-5).Patients with incisional hernia were treated with either hernia corset (n-7) or surgical repair using direct closure or insertion of mesh (n-14).

• Brand Name: PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NONABSORBABLE
• 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: 7449805
• MDR Text Key: 106143588
• Report Number: 2210968-2018-72237
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• 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
• Report Date: 03/26/2018

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: 03/26/2018
• Initial Date FDA Received: 04/22/2018
• 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