MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION XENFORM MESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PRO

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

Patient Problems Bacterial Infection (1735); Fever (1858); Headache (1880); High Blood Pressure/ Hypertension (1908); Seizures (2063); Urinary Retention (2119); Urinary Tract Infection (2120); Weakness (2145); Dizziness (2194); Anxiety (2328); Injury (2348); Sedation (2368); Shaking/Tremors (2515); No Code Available (3191)

Event Date 08/08/2014

Event Type  Injury  

Manufacturer Narrative

Alternative patient id: (b)(6). The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown. Study name: (b)(6). (b)(4). The complainant indicated that the xenform device is implanted and is not expected to be returned for evaluation; therefore a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

Note: this manufacturer report pertains to one of two devices used during different procedures. It was reported to boston scientific corporation that a xenform device was implanted into the patient during a pelvic floor repair procedure with xenform including vaginal approach hysteropexy, and cystocele repair performed on (b)(6) 2014. An obtryx ii halo device was also implanted into the patient during a concomitant cystocele repair with native tissue, transobturator sling placement, and right retrograde pyelogram. The procedure was completed without complications. According to the complainant, on (b)(6) 2014, the patient experienced urinary retention following her procedure, and she was discharged with a foley catheter. On (b)(6) 2014, the patient presented for "confusion and thrashing around. " the initial suspicion was for urinary tract infection and sepsis, but a uti was not found. It was ultimately determined that the patient was having non-convulsive status epilepticus, and anti-seizure medication was started. The cause of the seizures was thought to be reversible posterior leukoencephalopathy syndrome (rpls) incited by bladder spasms secondary to an occluded catheter causing an increase in blood pressure and localized edema when the blood pressure came down. An mri did not reveal any recent strokes. It was noted that she may sustain permanent damage as a result of the delayed diagnosis, complicated by her prior strokes and concurrent diabetes. The patient was hospitalized and a tracheostomy tube placed and mechanical ventilation provided for respiratory failure. Treatment was also provided for multiple electrolyte disturbances, candiduria (from foley catheter placement), and the urinary catheter was replaced. On (b)(6) 2014, the patient was discharged to a long-term care facility for continued recovery. She was then moved to an inpatient rehab where her tracheostomy tube and peg tube were removed. In (b)(6) 2014, the patient developed fevers and was diagnosed with a klebsiella uti, and she was treated with levaquin. Shortly thereafter, she experienced increased somnolence, decreased appetite, weakness to the point of being unable to stand, tremors in her hands, and dizziness. On (b)(6) 2014, she presented to the emergency department and was subsequently admitted to the hospital. Clostridium difficile screen was positive. Electroencephalogram (eeg) was essentially normal. On (b)(6) 2014, the patient was discharged to a skilled nursing facility with a foley catheter in place. A note was made in her discharge summary that she was to be evaluated on (b)(6) 2014 for transvaginal tape removal. On (b)(6) 2014, the patient missed one of the three scheduled in-and-out straight catheterizations earlier in the day at the skilled nursing facility and developed a headache and became agitated. Catheterization was done at that time which removed 200 ml of urine, but the patient continued to be agitated and was sent to the er. She presented to the er with significantly elevated blood pressure with some confusion and agitation which were suspected to be secondary to urinary retention. No seizure activity was noted, but seizure activity was seen via eeg. Anti-seizure medication was increased. The acute urinary retention was noted to be from a "physically deconditioned bladder, rather than any bladder outlet obstruction. " the patient was discharged home with her family and a plan for in home health care, and the in-and-out catheterizations were scheduled for four times daily. The investigator assessed the event as a serious adverse event due to the hospitalization, moderate in severity, pelvic floor related, possibly related to the index procedure, and possibly related to the study device (xenform). The site confirmed that the patient had obtryx sling removal on (b)(6) 2014 by a different provider.

• Brand Name: XENFORM
• Type of Device: MESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PRO
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): TEI BIOSCIENCES INCORPORATED; 7 elkins street; boston MA 02127
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 10367931
• MDR Text Key: 201846809
• Report Number: 3005099803-2020-02970
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060984
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 08/05/2020 Patient Sequence Number: 1