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	Unspecified Infection (1930); Pain (1994); Urinary Retention (2119); Abnormal Vaginal Discharge (2123); Discomfort (2330); Obstruction/Occlusion (2422); Constipation (3274)
Date of Event	03/09/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).(b)(4).Study name: (b)(6).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 device was implanted during a pelvic floor repair procedure with xenform including vaginal-approach hysteropexy procedure performed on (b)(6) 2016.According to the complainant, on (b)(6) 2016, the patient presented with bladder outlet obstruction and was admitted to the hospital on (b)(6) 2016.She underwent a revision prolapse surgery and the device was completely removed from the posterior vaginal wall.She was then discharged on (b)(6) 2016 and the event of obstruction resolved on (b)(6) 2016.
Event or Problem Description
It was reported to boston scientific corporation that a xenform device was implanted during a pelvic floor repair procedure with xenform including vaginal-approach hysteropexy procedure performed on (b)(6) 2016.According to the complainant, on (b)(6) 2016, the patient presented with bladder outlet obstruction and was admitted to the hospital on (b)(6) 2016.She underwent a revision prolapse surgery and the device was completely removed from the posterior vaginal wall.She was then discharged on (b)(6) 2016 and the event of obstruction resolved on (b)(6) 2016.Additional information received on november 30, 2018.On (b)(6) 2016, aside from bladder outlet obstruction, the patient also experienced fecal impaction, wound infection in the posterior compartment with symptoms of difficulty voiding, increased vaginal pain, malaise, and vaginal drainage.The patient reportedly had tried multiple stool softeners and enemas and was able to have a bowel movement.On (b)(6) 2016, the patient was admitted to the hospital and underwent an inpatient surgical intervention including transurethral mobilization of sling, and complete explant of the study device from the posterior vaginal wall.The patient was then discharged from the hospital on (b)(6) 2016.She was also treated with iv antibiotics for the wound infection.All events were resolved on (b)(6) 2016.The investigator assessed the wound infection and fecal impaction events as moderate in severity and pelvic floor related.The assessment of the relationship of this to the procedure and/or device has not yet been provided.
Additional Manufacturer Narrative
Patient id: (b)(6).Study name: (b)(4).
Additional Manufacturer Narrative
Patient id:(b)(6) the following problem codes capture the following reportable events: 2422 - obstruction.2119 - urinary retention.1930 - infection.1994 - pain.Study name: (b)(6) xenform a/a postmarket.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.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.Updated.
Event or Problem Description
It was reported to boston scientific corporation that a xenform device was implanted during a pelvic floor repair procedure with xenform including vaginal-approach hysteropexy procedure performed on (b)(6) 2016.According to the complainant, on (b)(6) 2016, the patient presented with bladder outlet obstruction and was admitted to the hospital on (b)(6) 2016.She underwent a revision prolapse surgery and the device was completely removed from the posterior vaginal wall.She was then discharged on (b)(6) 2016 and the event of obstruction resolved on (b)(6) 2016.On (b)(6) 2016, aside from bladder outlet obstruction, the patient also experienced fecal impaction, wound infection in the posterior compartment with symptoms of difficulty voiding, increased vaginal pain, malaise, and vaginal drainage.The patient reportedly had tried multiple stool softeners and enemas and was able to have a bowel movement.On (b)(6) 2016, the patient was admitted to the hospital and underwent an inpatient surgical intervention including transurethral mobilization of sling, and complete explant of the study device from the posterior vaginal wall.The patient was then discharged from the hospital on (b)(6) 2016.She was also treated with iv antibiotics for the wound infection.All events were resolved on (b)(6) 2016.The investigator assessed the wound infection and fecal impaction events as moderate in severity and pelvic floor related.The assessment of the relationship of this to the procedure and/or device has not yet been provided.The events of wound infection and fecal impaction have been assessed by the investigator as definitely related to the procedure, and definitely related to the device.For the event of wound infection, it was determined to be in the area of the suture line, less than or equal to 1cm, and associated with spontaneous pain.

• 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: 7846961
• Report Number: 3005099803-2018-60282
• Device Sequence Number: 13787520
• Product Code: FTM
• UDI-Device Identifier: 08714729773764
• UDI-Public: 08714729773764
• 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
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/26/2019

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: 09/30/2016
• Device Model Number: M0068302450
• Device Catalogue Number: 72920
• Device Lot Number: 0001404013
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/09/2018
• Supplement Date Received by Manufacturer: 11/30/2018; 08/01/2019
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 12/28/2018; 08/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 34 YR
• Patient Weight: 72