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

Model Number	M0068302450
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/18/2011
Type of Reportable Event	Serious Injury
Event or Problem Description
Note: this manufacturer report pertains to one of three devices implanted during the same procedure.Refer to manufacturer report numbers 3005099803-2023-02917 for the second xenform device and 3005099803-2023-02918 for the obtryx device.It was reported to boston scientific corporation that a xenform device was implanted into the patient during a vaginal hysterectomy with anterior and posterior colporrhaphy + transobturator mid-urethral sling with cystoscopy + intraarcus graft + intraspinous graft procedure performed on (b)(6) 2011 due to symptomatic pelvic relaxation: uterine procidentia, third degree cystourethrocele, third degree rectocele and mixed urinary incontinence.The patient was transported to the recovery room in satisfactory condition.As reported by the patient's attorney, the patient experienced an unknown injury.
Additional Manufacturer Narrative
Block b3 date of event: date of event was approximated to on (b)(6) 2011, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeons are: dr.(b)(6).Block h6: imdrf patient code e2401 captures the reportable event of unspecified injury.Imdrf impact code f12 has been used in the light of the patient sought legal recourse for an unspecified personal injury related to the device.

• 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): INTEGRA LIFE SCIENCES SALES LLC; 311 enterprise drive; plainsboro NJ 08536
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17050382
• Report Number: 3005099803-2023-02916
• Device Sequence Number: 11632803
• Product Code: FTM
• UDI-Device Identifier: 08714729773764
• UDI-Public: 08714729773764
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K060984
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• 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): 06/02/2023

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: 08/31/2013
• Device Model Number: M0068302450
• Device Catalogue Number: 830-245
• Device Lot Number: 0001105029
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2011
• 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: 68 YR
• Patient Sex: Female