MAUDE Adverse Event Report: ETHICON INC. GYNECARE TVT OBTURATOR SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number 810081L

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abscess (1690); Death (1802); Erythema (1840); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Sepsis (2067); Urinary Retention (2119); Vomiting (2144); Discomfort (2330); Obstruction/Occlusion (2422); Hematuria (2558); No Code Available (3191)

Event Date 11/01/2015

Event Type  Death  

Manufacturer Narrative

(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Event Description

It was reported that the patient underwent a sling procedure in 2010.The patient was found to have evidence of bladder outflow obstruction following the procedure.The patient underwent long-term catheterization and ultimately a suprapubic catheter, which was reported to be associated with staphylococcal sepsis.In 2014, the patient developed a mycotic aortic aneurysm.The patient underwent emergency surgery and died in the post-operative period.Additional information has been requested.

Manufacturer Narrative

(b)(4).The patient underwent a sling procedure during a hospital admission on (b)(6) 2010.It was also reported that, at discharge, there were no obvious complications, with a satisfactory post-operative recovery and planned four months follow-up.Ten months later, the doctor acknowledged that the patient had been unable to attend scheduled follow-up.Two years later, the patient experienced acute kidney injury with raised creatinine and urea and a history of several recent urinary tract infections and she was admitted to the hospital.The patient was treated with intravenous fluids, antibiotics and urinary catheterization.The scan had shown moderate bilateral hydronephrosis and chronic urinary retention.The patient was discharged with a urinary catheter.But she returned next day, on (b)(6) 2013, as the catheter had fallen out of her abdomen and the patient was unable to pass urine naturally and it was leaking from the recent abdominal incision site.On (b)(6) 2013, the patient experienced hot and shivering from the previous night.On examination, it was noticed hardness underneath the catheter stoma, which was indulated and erythematous.The patient temperature was normal, but her c-reactive protein was raised.The doctor opined that the patient had a urinary tract infection and cellulitis, but she was not keen for the hospital admission.The patient was commenced on flucloxacillin and trimethoprim.On (b)(6) 2013, the doctor opined that the patient had subjectively improved.During the examination, the patient presented cellulitis over the mons pubis area of her pelvis with no fluid collection.On (b)(6) 2013 the patient notified a doctor that she was passing blood from her urethra and blood-stained urine from her suprapubic catheter, and still had incomplete bladder emptying.The doctor opined that removal of catheter is not an option.On (b)(6) 2013, the cystoscopy was performed, which showed no mesh in urethra and was well apposed.But there was patchy bladder inflammation with an area of slough that could not be dislodged, so it was unclear what lay beneath this.On (b)(6) 2014, the patient underwent the ctu test.It was reported that there had been infections around the catheter site, which was possibly leaking urine, and the catheter had been changed without improvement.The patient was in a lot of discomfort and experienced over-granulation at the catheter site.On (b)(6) 2014, the patient¿s case was reviewed with ctu findings.The doctor opined that there was possibly infection of the pubic bone but this was felt to relate to the previous radiotherapy.The left lower ureter was slightly thickened and the doctor opined that it was more likely related to inflammation.There was also a soft tissue mass in the right renal pelvis extending into the right ureter.The doctor opined that this was more likely related to a possible blood clot.In (b)(6) 2014, the patient underwent a blood transfusion for anemia, cystoscopy and bilateral ureteroscopy with the replacement of the suprapubic catheter.Investigation of the bladder showed squamous metaplasia with the previous area of slough now gone and the cause of anemia remained unresolved.The suprapubic catheter wound has appeared inflamed with granulated tissue and was cauterized.The patient was discharged.Next month, the patient was admitted with coffee-ground vomit and a recent history of increased ibuprofen usage for right hip pain and gastroscopy was performed, no ulceration/inflammation was found.Extensive body and bone scans showed an abscess on the right buttock and fluid collection was drained from the abscess under ultrasound guidance, with washout of the right hip.The patient was placed on intravenous antibiotics due to staphylococcus aureus and peripheral intravenous catheter was inserted.At discharge, the treatment plan was for three months of ceftriaxone and oral rifampicin.The patient had a further emergency admission with staphylococcal septicemia and ct scan showed an extensive mycotic aortic aneurysm with extensive destruction of the symphysis pubis and possibly osteomyelitis.The patient underwent a laparotomy with repair of aneurysm, bilateral axillo-femoral bypasses and left nephrectomy.The suprapubic catheter was removed as the site was inflamed and replaced with urethral catheter.The patient¿s condition was initially stable but then progressively deteriorated and two days later, the patient died.

• Brand Name: GYNECARE TVT OBTURATOR SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20 2000 neuchatel; neuchatel ; SZ
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 5265360
• MDR Text Key: 32642824
• Report Number: 2210968-2015-19557
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K033568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2011
• Device Catalogue Number: 810081L
• Device Lot Number: 3447279
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/30/2010
• 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): Death; Required Intervention
• Patient Age: 77 YR