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

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

Patient Problems Pain (1994); Seroma (2069); Discomfort (2330); 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.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.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? citation: hernia (2019) 23:375¿385.Https://doi.Org/10.1007/s10029-019-01911-1.(b)(4).

Event Description

It was reported via a journal article"title : robotic retromuscular ventral hernia repair and transversus abdominis release: short-term outcomes and risk factors associated with perioperative complications." author : f.Gokcal, s.Morrison, o.Y.Kudsi.Citation: hernia (2019) 23:375¿385.Https://doi.Org/10.1007/s10029-019-01911-1.The objective of this study was to describe our 90-day outcomes in patients who underwent robotic retromuscular ventral hernia repair (rrvhr).A total of 101 patients (53 females, 48 males), mean cohort age of 57.3 ± 12.9 sd, underwent rrvhr between february 2013 and september 2018.Of the 101 patients, 54 patients (30 females, 24 males), age in years (mean ± sd) of 59.1 ± 12.2, underwent rrvhr with transversus abdominis release (tar+) while the remaining 47 patients (23 females, 14 males), age in years (mean ± sd) of 55.1 ± 13.6, underwent rrvhr without tar (tar-).Primary closure of the anterior fascial defect was performed by running a long-lasting absorbable barbed suture (stratafix 0¿ on ct-1 needle, ethicon, somerville, nj, usa) under reduced intra-abdominal pressure (4 8 mmhg).One of the preferred mesh types in the tar+ group was the physiomesh¿ (ethicon inc., somerville, nj, usa) used in 1.9% of the patients.During t hospital stay, one or more complications were reported in 28 patients (28.8%).Presence of any complication was significantly higher in the tar + group as compared to the tar - (p = 0.028).Evaluation of 99 patients (98% of all cohorts) within the 1-month follow-up period for postoperative complications was done and 38 patients (38.4%) encountered complications.In a 3-month follow-up visit (90.1% of the entire cohort), further postoperative complications were noted in 7 patients (7.7%).The most frequent complication was persistent post-surgical pain in these time frames.Only one patient who suffered from chronic pain, after further follow-up visits.The complication rate did not differ at 1 month and 3-month periods between tar+ and tar- groups.Pain exacerbation during hospital stay was noted in 8 patients in tar+ group and 4 patients in tar- group.Pain/discomfort reported from discharge to 30-days post-op (n= 99) was noted in 15 patients in tar+ group and 14 patients in tar- group.Seroma reported from discharge to 30-days post-op (n= 99) was noted in 4 patients in tar+ group and 4 patients in tar- group.Pain/discomfort reported from 30-days to 90 days post-op (n:91) was noted in 5 patients in tar+ group and 2 patients in tar- group.Seroma.Of the 8 patients with seroma, only 1 in the tar- group required treatment with percutaneous drainage (clavien¿dindo grade- iiia) while the remaining 7 seroma cases resolved spontaneously.The authors concluded that rrvhr is safe and feasible.Tar patients may be more prone to complications in the immediate post-operative period, however, the difference between patients with and without tar adjuncts resolved at 90 days.Our study results showed that incarceration was the only factor associated with the development of any complication in rrvhr.

• Brand Name: PHYSIOMESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL
• 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 ; GM
• Manufacturer Contact: kara ditty-bovard ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 6107428552
• MDR Report Key: 9520716
• MDR Text Key: 189040890
• Report Number: 2210968-2019-91299
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093932
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/05/2019
• 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