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 Failure to Anastomose (1028); Urinary Tract Infection (2120); Obstruction/Occlusion (2422); Unspecified Tissue Injury (4559)

Event Date 09/15/2019

Event Type  Injury  

Event Description

Title: modified wallace anastomotic technique reduces ureteroenteric stricture rates after ileal conduit urinary diversion this study aimed to compare perioperative outcomes, complications and anastomotic stricture rate in a contemporary series of patients who underwent open radical cystectomy (rc) with modified wallace anastomotic technique versus traditional ileal conduit.A total of 140 (group 1: n=70; group 2: n=70) patients who underwent radical cystectomy (rc)/ pelvic lymph node dissection (pnld) were included in the study.Plnd was performed in 60 patients (85.7%) in group i and in 63 patients (90%) in the group ii.A long and straight incision of the mesentery, on both ends, was made using the harmonic focus long shears (ethicon endo-surgery inc.Cincinnati, oh, usa).A side-to-side ileo-ileal anastomosis was performed using a pds 4-0 continuous suture.The apex of one ureter was sutured to the apex of the other ureter with 4-0 vicryl or polydioxanone (pds) sutures.In group i, the posterior medial walls of spatulated ureters were sutured together with continuous 4-0 vicryl suture (the knots tied to the outside), over a 6 ch ureteric catheter, while the lateral edges of the newly conjoined ureters were anastomosed to the proximal end of an open ileal conduit segment, using 4-0 pds interrupted suture, according to the standard wallace i technique.In group ii, the isolated ileal segment was 20cm long, while each ureter was spatulated for 2.5-3cm and initial 5-0 pds suture was placed at the apex of both ureters through all layers.Next, the needle reverses posteriorly to facilitates further muco-mucosal running suture of everted posterior medial ureteral wall edges (4-0 vicryl), over a 6 ch or 8 ch ureteric catheter.Lateral edges of the newly formed ureteral plate and the everted ileal mucosa (from the proximal end of conduit segment) were anastomosed in a running fashion, while the outer anastomotic wall was augmented with sero-serosal interrupted suture (vicryl 4-0 or pds 4-0).At the end, conduit was retroperitonealized with the ureterointestinal anastomosis being placed in the retroperitoneum.This was accomplished by suturing the serosa of the conduit to the posterior peritoneum, above the anastomosis.Finally, in both groups, an abdominal stoma in the right iliac fossa was performed.The distal end of the ileal segment was first anchored to the rectus fascia with interrupted 4-0 vicryl sutures and then to the skin, while an 18 ch folley catheter was placed in the conduit to allow for postoperative flushing.Post-randomization distributions of group demographics, disease characteristics, and pathologic staging were not significantly different.The mean (sd) follow-up time was 26.1 (5.7) months in group i and 25.2 (4.8) months in group ii.During the follow-up period, anastomotic stricture was observed in 8 patients (12%) from the first and 2 patients (3%) from the second group (95% confidence interval for difference, p <0.05) four patients from group i and one patient from group ii underwent antegrade dj stent placement, one patient from group i and the patient from group ii received percutaneous nephrostomy tube (pcn) as a definitive treatment.The remaining 3 patients (all in group i) underwent uretero-intestinal reimplantation.Two patients from the group i (2.8%) developed left ureteral stenosis, proximal to the anastomotic site, both were managed conservatively.No patients from group ii developed left ureteral stenosis.The anastomotic leakage rate was significantly higher in fi rst group (17% vs.8.5%, p< 0.05), while patient-reported hrqol outcomes were similar between groups after the 12 month follow-up period.Reported postop complications included n=10 anastomotic strictures, n=2 left ureteral stenosis, n=18 anastomotic leakage, n=39 pyelonephritis and n=28 paralitic ileus.

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, demographics 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 surgeon believe that ethicon products (vicryl suture and pds suture) involved caused and/or contributed to post-op complications (anastomotic strictures, left ureteral stenosis, anastomotic leakage, pyelonephritis and paralitic ileus) described in the article? please specify.Does the surgeon believe there was any deficiency with the ethicon products (vicryl suture and pds suture) used in this study? if yes, please provide patient demographics for the patients that experienced the post-operative complications (anastomotic strictures, left ureteral stenosis, anastomotic leakage, pyelonephritis and paralitic ileus)? were all these cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Citation: doi: 10.1590/s1677-5538.Ibju.2019.0417.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Events were submitted via 2210968-2021-09441.

Manufacturer Narrative

Date sent to the fda: 11/2/2021.Additional information was requested, and the following was obtained: according to our knowledge and experience, we do not believe that ethicon products influenced/caused higher post-op complications rate among patients treated in our study.We think that surgical technique played the major role in this particular study, not the suture material.Moreover, vicryl and pds sutures have been used for many years in our department, without significant correlation with postoperative complications.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.

• 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
• MDR Report Key: 12602417
• MDR Text Key: 283082778
• Report Number: 2210968-2021-09442
• 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
• Type of Report: Initial,Followup
• Report Date: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2021
• 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: 10/11/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention