MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO MESH UNKNOWN PRODUCT; MESH, SURGICAL, POLYMERIC

Catalog Number ULTRAPROMUNK

Device Problem Migration (4003)

Patient Problems Erosion (1750); Fever (1858); Unspecified Infection (1930); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Perforation of Vessels (2135); Injury (2348); Obstruction/Occlusion (2422); Blood Loss (2597)

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.Citation: neurourology and urodynamics.2019;38:1874-1882.Doi: 10.1002/nau.24083.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.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.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 involved?.

Event Description

It was reported in a journal article with title: medium-term outcome of laparoscopic sacrocolpopexy using polyvinylidene fluoride as compared to a hybrid polyglecaprone and polypropylene mesh: a matched control study.The authors presented 2-year anatomical and functional outcomes as well as the occurrence of graft-related complications (grc) in unselected consecutive patients undergoing laparoscopic sacrocolpopexy (lscp) with polyvinylidene fluoride (pvdf) as compared to a matched cohort operated with hybrid polypropylene containing a resorbable polyglecaprone (pp + pg).This retrospective report deals with the first 105 patients (age: 67 [58-73] years; bmi: 26 [25-29]) in whom lscp was done using a pvdf implant (cases) (pvdf group).They were matched one-to-one to 105 controls (age: 68 [60-75] years; bmi: 25 [23-28]) operated before, using a hybrid pp + pg (ultrapro; ethicon) (pp + pg group).During the procedure, the anterior and posterior leaf were cut out of a large flat mesh.The mesh covering the anterior and posterior vaginal wall had a width of 5 cm, and a length that was based on the length of the vaginal dissection.The posterior leaf was in its sacral arm 3 to 4 cm in width.The mesh was sutured to the vagina with multiple, slowly resorbable polydioxanone sutures (pds; ethicon) in rows of three for each 2 cm of vagina covered.The posterior leaf was suspended tension free and fixed to the anterior vertebral ligament with a minimum of three staplers (ems; ethicon).The anterior leaf was sutured to the posterior mesh using up to three nonresorbable polyester sutures (ethibond; ethicon).Any excess amount of mesh was removed after fixation.Meshes were covered by peritoneum using one or more polyglecaprone 0 sutures (monocryl 0; ethicon).Reported complication in the pvdf group included vaginal wall perforation (n-1) which was closed primarily by laparoscopy, needle detached spontaneously from the suture (n-1) but could be easily retrieved, vascular injury (n-2), postoperative fever (n-1) in which the patient received antibiotics, persistent stress incontinence (n-9) in which patients the underwent reintervention, persistent urge incontinence (n-14), persistent obstructive voiding (n-2), persistent constipation (n-12), persistent obstructive defecation (n-2) in which the patients underwent redo-rectopexies, persistent dyspareunia (n-4), de novo stress incontinence (n-18) in which patients the underwent reintervention, de novo urge incontinence (n-15), de novo obstructive voiding (n-3), de novo constipation (n-15), de novo fecal incontinence (n-4), de novo dyspareunia (n-1), mesh exposure (n-2) which were successfully managed with vaginal excision under general anesthesia, bleeding or vaginal discharge (n-1), pelvic organ prolapse (n-2) in which the patients was reoperated (1 anterior repair and 1 posterior repair), and recurrent or persistent bulge (n-6).Reported complications in pp + pg group included bladder injury (n-1) which was closed primarily by laparoscopy, vaginal wall perforation (n-3) which was closed primarily by laparoscopy, vascular injury (n-1), small bowel obstruction (n-1) in which the patient underwent adhesiolysis, urinary tract infection (n-14) in which the patient received antibiotics, vaginal infection (n-1) in which the patient received antibiotics, postoperative fever (n-3) in which the patient received antibiotics, urinary retention (n-1), persistent stress incontinence (n-9) in which patients the underwent reintervention, persistent urge incontinence (n-18), persistent obstructive voiding (n-7), persistent constipation (n-8), persistent fecal incontinence (n-2), persistent dyspareunia (n-2), de novo stress incontinence (n-15) in which patients the underwent reintervention, de novo urge incontinence (n-11), de novo obstructive voiding (n-3, de novo constipation (n-10), de novo fecal incontinence (n-7), de novo dyspareunia (n-3), mesh exposure (n-1) which were successfully managed with vaginal excision under general anesthesia, bleeding or vaginal discharge (n-1), pelvic organ prolapse (n-1) in which the patient reoperated (combined anterior and posterior repair), coccydynia (n-1) in which the patient insisted removal of the staples on the promontory, which was done successfully yet symptoms persisted, and recurrent or persistent bulge (n-16).In conclusion, a similar patient satisfaction and anatomical outcomes at level-i in patients undergoing lscp with pvdf as compared to matched-controls in whom a pp + pg mesh was used.Furthermore, the overall complication rate was low in both groups, suggesting both meshes can be safely and effectively used for lscp.

• Brand Name: ULTRAPRO MESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; norderstedt 22851 ; GM 22851
• Manufacturer Contact: kara ditty-bovard ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 6107428552
• MDR Report Key: 9833609
• MDR Text Key: 193062805
• Report Number: 2210968-2020-01482
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K033337
• 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: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ULTRAPROMUNK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2020
• 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