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

Model Number	M0068302430
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/21/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a xenform graft was implanted during sling operation for incontinence, transvaginal repair of cystocele, transvaginal colpopexy using sacrospinous fixation, partial vaginectomy/excision of vaginal mucosa mass, cystoscopy, and removal of previous prolene mesh sling material procedure performed on (b)(6) 2016, to treat a patient with cystocele, vaginal prolapse, vaginal mucosal lesion, urinary stress incontinence, and dyspareunia.It was noted that there was hypertrophied vaginal mucosa around the region of the bladder neck that appeared suspicious.It was excised and repaired.There were no patient complications during the implant procedure.Patient tolerated the procedure well and was transferred to the recovery room in satisfactory status.A vaginal packing was inserted.As reported by the patient's attorney, the patient experienced an unspecified injury.
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2016, implant date, as no event date was reported.Initial reporter name and address: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).(b)(4).

• Brand Name: XENFORM
• Common Device Name: 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: 15815330
• Report Number: 3005099803-2022-06732
• Device Sequence Number: 12225009
• Product Code: FTM
• UDI-Device Identifier: 08714729774464
• UDI-Public: 08714729774464
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K060984
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: M0068302430
• Device Catalogue Number: 830-243
• Device Lot Number: 0001606002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2022
• Initial Report FDA Received Date: 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Sex: Female