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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Myocardial Infarction (1969); Pneumonia (2011); Hernia (2240); Ulcer (2274); Obstruction/Occlusion (2422); Post Operative Wound Infection (2446); Blood Loss (2597); Fluid Discharge (2686)

Event Date 02/10/2019

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 additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.Does the author/surgeon believe that ethicon products (pds ii suture and prolene suture) involved caused and/or contributed to the post-operative complications described in the article? does the author/surgeon believe there was any deficiency with the ethicon products (pds ii suture and prolene suture) used in this procedure? were these cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? citation: international journal of diabetes in developing countries (october¿december 2019) 39(4):611¿617.Doi: https://doi.Org/10.1007/s13410-019-00723-4.

Event Description

Title: long-term outcomes of diabetes after laparoscopic roux-en-y gastric bypass in a lebanese bariatric practice.This retrospective study aims to evaluate the impact of rygb on dm in our patient population.We retrospectively reviewed our database and selected 107 morbidly obese patients with type ii dm who underwent primary laparoscopic rygb from 2005 to 2015.Diabetic patients were older (48.6 ± 8.2 vs.38.3 ± 9.9 years, p < 0.001), had similar male gender (55.1% vs 54.3%) and bmi (44.0 ± 7.2 vs.45.5 ± 7.1).The gastrojejunal anastomosis was performed in a hand-sewn fashion using two layers of 2¿0 pds (ethicon) over a 36french orogastric tube.The common enterotomy was closed by a single-layer 2-0 pds suture (ethicon).The mesenteric defect at the jj anastomosis was closed with 2-0 prolene sutures (ethicon) in a running fashion in all patients.Early (= 30-day) and late (> 30-day) complications included leak, bleeding, small bowel obstruction, wound infection (n=1), pneumonia (n=2), mi (n=1), peterson hernia (n=3), jejunojejunostomy hernia (n=1), duodenal ulcer (n=1), gallstone disease (n=10), hiatal hernia (n=1), incisional hernia (n=2)and anemia requiring iv iron (n=16).This is the first report from the mena region on the long-term outcomes of rygb in the treatment of type ii dm.Our results are similar to those in the international literature highlighting the effectiveness of rygb in the treatment of dm.Through our literature review, we noticed the lack of enough studies in the field of bariatric surgery in the mena region.Therefore, we recommend researchers from this region to conduct larger prospective studies.We also recommend future studies to compare bariatric outcomes including dm remission between middle eastern and other populations and ethnicities as this could explore outcome differences between these populations.

• 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
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 10744995
• MDR Text Key: 216652712
• Report Number: 2210968-2020-08391
• 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,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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