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

Device Problem Insufficient Information (3190)

Patient Problems Hernia (2240); Obstruction/Occlusion (2422); Post Operative Wound Infection (2446); 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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.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: surg endosc (2016) 30:2367¿2373.

Event Description

It was reported via journal article title: primary non-closure of mesenteric defects in laparoscopic rouxen-y gastric bypass: reoperations and intraoperative findings in 146 patients.Authors: tarik delko, marko kraljevic, thomas ko¨stler, lincoln rothwell, raoul droeser, silke potthast, daniel oertli, and urs zingg.Citation: surg endosc (2016) 30:2367¿2373; doi 10.1007/s00464-015-4486-1; published online: 3 september 2015.The aim of this study was to analyze clinical, imaging and intraoperative findings in patients that underwent elective or acute surgical closure of mesenteric defects following primary laparoscopic roux-en-y gastric bypass (lrygb).Between the periods of 2000 to 2003, a total of 585 laparoscopic rygb were performed, 269 patients with non-closure of mesenteric defects and 316 with primary closure of mesenteric defects (77 with vvll-lrygb and 239 with proximal lrygb) were identified.One hundred and forty-six patients (59.3 %) with open mesenteric defects had reoperations and represented the main cohort for analysis.One hundred and one patients (37.5 %) did not undergo any further reoperations and were not further analyzed.The standard technique of the authors until november 2008 consisted of a very, very long limb lrygb (vvlllrygb).One patient died prior to 2008 of ischemic bowel and associated sepsis due to a strangulated meso-jejunal hernia.From november 2008 onwards, the bilio-pancreatic limb was orientated from the left and mesenteric defects were routinely closed with non-absorbable interrupted sutures (prolene 3-0) following lrygb.Our experience with non-closure led to the modification of our surgical technique and closure of all potential defects with non-absorbable (prolene 3-0) interrupted sutures.Patients who present with abdominal pain after lrygb with open mesenteric defects are planned for diagnostic laparoscopy.In case of open defects, closure is performed using non-absorbable interrupted suture.Early surgical morbidity (3 %) consisted of 1 cystic stump leak after concomitant cholecystectomy, 1 wound infection and 3 small bowel obstruction (sbo)¿s due to kinking at the entero-enterostomy.In conclusion, the spontaneous closure rate of mesenteric defects due to post-operative inflammation or adhesions is very low leaving a life-long risk for ih.Without closure of mesenteric defects the incidence of ih is unacceptably high, and thus the closure of the mesenteric defects at time of primary lrygb is recommended.

• 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
• MDR Report Key: 7643803
• MDR Text Key: 112552710
• Report Number: 2210968-2018-73898
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K133356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/06/2018

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: 06/06/2018
• Initial Date FDA Received: 06/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention