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 Codes	Edema (1820); Pain (1994); Swelling (2091); Disability (2371)
Date of Event	06/29/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Tga device incident report reference no (b)(4); submitted to tga (therapeutic goods administration) by the patient.(b)(4).The complaint device 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 or Problem Description
It was reported to boston scientific corporation that a xenform tissue repair matrix was implanted into the patient during a prolapse procedure performed on (b)(6) 2016 for the treatment of prolapse.According to the patient, after the procedure, the patient has experienced large swelling/edema that is obvious in a large square shape around the patient's tailbone region/lower spine.Reportedly, the patient's tailbone would ache and sting after sitting for longer than 30 minutes.In addition, the patient is unable to lift more than 3kg again and is only able to sleep on back.Subsequently, the patient takes mersyndal forte or mersyndal capets to help with pain in the nighttime and is also on antidepressants, trialled lyrica for pain, and gabapentin and beta blockers plus mobic and somac to help with pain and swelling.The patient also regularly sees a clinical therapist since her prolapse surgery.Boston scientific has been unable to obtain additional information regarding the event to date.

• 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
• MDR Report Key: 10900265
• Report Number: 3005099803-2020-05630
• Device Sequence Number: 19511454
• Product Code: FTM
• UDI-Device Identifier: 08714729773764
• UDI-Public: 08714729773764
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K060984
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/24/2020

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 Model Number: M0068302450
• Device Catalogue Number: 830-245
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2018
• Initial Report FDA Received Date: 11/25/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention