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

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Obstruction/Occlusion (2422); 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: int urogynecol j (2007) 18:1237¿1241; doi 10.1007/s00192-007-0346-4; published online: 27 march 2007.(b)(4).

Event Description

It was reported via journal article: ¿title: small bowel obstruction after vaginal vault suspension: a series of three cases¿ authors: beri ridgeway, matthew d.Barber, mark d.Walters and marie fidela r.Paraiso citation: int urogynecol j (2007) 18:1237¿1241; doi 10.1007/s00192-007-0346-4; published online: 27 march 2007.This case study presented a thorough review of the literature that revealed no previous reports of primary vaginal reconstructive surgery leading to small bowel obstruction (sbo) in female patients.In case 1, a (b)(6) multiparous woman with no previous abdominal surgeries presented to the urogynecology clinic with symptomatic pelvic organ prolapse.During the surgery, one stitch of 0-prolene (ethicon, (b)(4)) and 0-pds (ethicon, (b)(4)) suture were placed in the mid-portion of the uterosacral ligaments bilaterally.The pds sutures were then passed through the anterior and posterior vaginal cuff epithelium bilaterally and the prolene sutures were passed through the muscularis of the anterior and posterior vaginal wall bilaterally.On postoperative day 1, the patient developed nausea, vomiting, and abdominal distention, which worsened the following day.On postoperative day 2, a plain abdominal radiographic film revealed multiple dilated loops of small bowel consistent with early or partial small bowel obstruction.Conservative management including bowel rest, fluid resuscitation, and bowel decompression via a nasogastric tube was begun.However, after 8 days of conservative management without significant sustained improvement, surgical intervention was recommended.On day 14, the patient was able to tolerate a regular diet and was discharged home.In conclusion, the authors noted that a possible new trend of placing vaginal vault suspension sutures more proximal in the uterosacral ligament predisposes to small bowel obstruction.The patient¿s postoperative course was uncomplicated with the exception of a mild wound infection, which was treated with drainage and oral antibiotics.

• 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: 7449848
• MDR Text Key: 106139662
• Report Number: 2210968-2018-72251
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2018

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: 03/27/2018
• 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
• Patient Age: 69 YR