MAUDE Adverse Event Report: TORAX MEDICAL, INC. UNK FENIX MAGNETIC IMPLANT; IMPLANTED FECAL INCONTINENCE DEVICE

Catalog Number UNK FENIX MAGNETIC IMPLANT

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189); Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Wound Dehiscence (1154); Cyst(s) (1800); Fistula (1862); Hematoma (1884); Hemorrhage/Bleeding (1888); Pain (1994); Perforation (2001); Pocket Erosion (2013); Urinary Retention (2119); Obstruction/Occlusion (2422); Swelling/ Edema (4577)

Event Date 03/21/2021

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 manufacturing 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: does the author/surgeon believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain.In the article it mentions bleeding.How was the bleeding controlled? did the patient have to have a blood transfusion?.

Event Description

It was reported via journal article: sacral nerve stimulation versus the magnetic sphincter augmentation device for adult faecal incontinence:the safari rct.Authors: david g jayne, annabelle e williams, neil corrigan, julie croft, alison pullan, vicky napp, rachel kelly, david meads, armando vargas-palacios, adam martin, claire hulme, steven r brown, karen nugent, jen lodge, david protheroe, sushil maslekar, andrew clarke, pasha nisar and julia m brown.Citation:jayne dg, williams ae, corrigan n, croft j, pullan a, napp v, et al.Sacral nerve stimulation versus the magnetic sphincter augmentation device for adult faecal incontinence: the safari rct.Health technol assess 2021;25(18).Issn 1366-5278 doi: 10.3310/hta25180.The objective of this study was to compare fenix with sacral nerve stimulation for the treatment of adult faecal incontinence in terms of safety, efficacy, quality of life and cost-effectiveness.The study was prematurely stopped in 2017 when the manufacturing company was bought by a multinational company and the the fenix¿ continence restoration system, or fenix¿ magnetic sphincter augmentation (msa) (torax medical, minneapolis, mn, usa), device was withdrawn from the market.Between 30 october 2014 and 23 march 2017, 322 participants were assessed for eligibility; 23 participants were registered as training cases, and 99 participants were randomised into the study (50 fenix and 49 sacral nerve stimulation).The baseline characteristics of the two groups were similar and in keeping with a population suffering from moderate to severe faecal incontinence.The median time from randomisation to fenix implantation was 57.0 days (range 4.0¿416.0 days).The median time from randomisation to temporary sacral nerve stimulation was 86.5 days (range 2.0¿699.0 days) and the median time from randomisation to permanent sacral nerve stimulation was 371.0 days (range 86.0¿918.0).Five out of 50 participants did not undergo fenix implantation, and 5 out of 49 participants did not undergo temporary sacral nerve stimulation.A total of 32 participants continued to permanent sacral nerve stimulation, of whom three did not have a device implanted.For the primary end-point analysis, 19 participants had missing data, meaning that there was complete data available for analysis for 80 out of 99 (80.8%) participants.Reported complications included: intaoperative complications in the fenix arm bleeding, cyst found in recto vaginal septum, and rectal perforation.Post operative complications in fenix arm: worsening constipation/obstructed defecation (n=18), rectal pain (n=14), device erosion (n=8), wound infection (n=7), device explant/reoperation (n=7), implant infection(n=5), bleeding/wound hematoma (n=4), neurological (n=3), lack or loss of efficiency (n=3), urinary retention (n=1), device failure/separation (n=1), other complications (increase discharge wound,pain, wound dehiscence, swelling at the edge of wound, poor evacuation/constipation, superficial dehiscence,pinching of skin around device, lack of control of bowels, wound pain, wound still not healed following explant, fistula, covering stoma and bleeding from prolapse (n=17)).In conclusion the safari study revealed inefficiencies in the treatment pathways for faecal incontinence, particularly for sacral nerve stimulation.The success of both fenix and sacral nerve stimulation was much lower than previously reported, with high postoperative morbidity in the fenix group.

• Brand Name: UNK FENIX MAGNETIC IMPLANT
• Type of Device: IMPLANTED FECAL INCONTINENCE DEVICE
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• Manufacturer Contact: kara ditty-bovard ; 4188 lexington avenue north; shoreview, MN 55126 ; 6107428552
• MDR Report Key: 12247839
• MDR Text Key: 264264888
• Report Number: 3008766073-2021-00148
• Device Sequence Number: 1
• Product Code: PMH
• Combination Product (y/n): N
• PMA/PMN Number: H130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK FENIX MAGNETIC IMPLANT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/09/2021
• 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