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 Problem Failure to Anastomose (1028)

Event Date 09/23/2021

Event Type  Injury  

Event Description

Title: modification of the indiana pouch ileo-caecal cutaneous continent urinary diversion: tubular ileal afferent limb for ureteral anastomosis has low stricture rate and allows ileal ureter replacement.The aim of the study was to introduce our new modification of the indiana pouch with a refluxing ureteral anastomosis in a tubular afferent ileal segment of the ileocaecal urinary reservoir.Between february 2008 and december 2020, 37 patients who underwent modified continent ileo-caecal pouches for urinary diversion when orthotopic bladder substitution was not possible were included in the study.There were 27 women and 10 men with a median age of 64 years (range, 43-80 years).During the construction of the modified indiana pouch, the ileo-ascendostomy is performed ventrally to the mesenteric branches of the isolated bowel in end-to-end fashion with a running single layer sero-muscular 4-0 pds suture (ethicon).For the colonic segment, isolated ileum is sutured in an upside-down v-shape with a running 3-0 pds (ethicon) and the ileum-plate is sutured to the opened caecum using the same technique to augment the caecum.The 8-cm terminal ileum and the caecum adjacent to the ileo-caecal valve are tapered anti-mesenterically over a 12 f catheter with a non-ethicon 9-cm straight stapler (manufacturer: unknown).The ileo-caecal valve is plicated with 3 to 4 lembert, non-resorbable, 3-0 mersilene sutures (ethicon).4 to 6 lembert sutures are applied along the 8 cm of tapered terminal ileum to further narrow the efferent limb and to invert the staple sutures.After completion of the pouch, the efferent limb is anastomosed to the umbilicus and along with the ileo-caecal valve fixed to the abdominal wall with 3 to 4 single 2-0 vicryl sutures (ethicon) to assure correct straight alignment later allowing easy access by catheterisation and to retroperitonealize the right wall of the pouch.The reported complications included ureteral anastomotic stricture (n=2), fistula between the pouch and the vaginal stump in a 43-year-old female patient (n=1), leak (insufficiency) of the ileo-ascendostomy in an obese 67-year-old female patient (n=1), formation of fistula between pouch and vaginal stump in a female patient (n=1).In conclusion, our modification of the indiana pouch cutaneous continent urinary diversion with the ureteral anastomosis to a tubular segment of the pouch is easy to perform and effective in reducing the rate of ureteral anastomotic strictures.By lengthening, the afferent tubular ileal segment, it additionally allows easy ureteral replacement.

Manufacturer Narrative

Product complaint#: (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? which specific ethicon products have been used during the procedures (product code, lot number)? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? 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.(b)(4).Related events captured via 2210968-2023-00029, 2210968-2023-00030, 2210968-2023-00031, 2210968-2023-00032, 2210968-2023-00034, 2210968-2023-00035.Citation: urol int 2022;106:180¿185; https://doi.Org/10.1159/000518561.

• Brand Name: PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16091655
• MDR Text Key: 306593506
• Report Number: 2210968-2023-00033
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/03/2023

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: 12/19/2022
• Initial Date FDA Received: 01/03/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female