MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPHOLD LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN

Model Number M0068318170

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

Patient Problem Erosion (1750)

Event Date 12/06/2016

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The complainant indicated that the device is disposed and will not 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

It was reported to boston scientific corporation that an uphold lite was used during a pelvic floor repair with uphold lite including apical vault suspension and cystocele repair procedure on (b)(6) 2015.According to the complaint, after the procedure, the patient presented with mesh exposure at the vaginal suture line.There was no treatment given and the event has not yet resolved.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.

Event Description

It was reported to boston scientific corporation that an uphold¿ lite was used during a pelvic floor repair with uphold lite including apical vault suspension and cystocele repair procedure on (b)(6) 2015.According to the complaint, after the procedure, the patient presented with mesh exposure at the vaginal suture line.There was no treatment given and the event has not yet resolved.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.Additional information received on december 21, 2017: on (b)(6) 2017, the patient presented with mesh exposure at the trocar passage in the vagina of less than 1 centimeter.No treatment was given and the event has not yet resolved.

Event Description

It was reported to boston scientific corporation that an uphold lite was used during a pelvic floor repair with uphold lite including apical vault suspension and cystocele repair procedure on (b)(6) 2015.According to the complainant, on (b)(6) 2016, the subject presented with mesh exposure of less than or equal to 1 cm at the vaginal area of suture line.No action was taken and the event resolved on (b)(6) 2017.The investigator assessed the event as mild in severity, pelvic floor related, definitely related to the procedure, definitely related to the device, and possibly related to the delivery device.On (b)(6) 2017, the subject presented with mesh exposure at the trocar passage of 2mm left lateral exposure.No action was taken and the event was resolved on (b)(6) 2018.The investigator assessed the event as mild in severity, pelvic floor related, definitely related to the procedure, definitely related to the device, and possibly related to the delivery device.

Manufacturer Narrative

Patient identifier: patient id: (b)(6).Problem code 1750 captures the reportable event of mesh exposure.Date rec¿d by mfr: study name: u8090 uphold lite.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.The complainant indicated that the device is implanted and the 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 Description

It was reported to boston scientific corporation that an uphold¿ lite was used during a pelvic floor repair with uphold lite including apical vault suspension and cystocele repair procedure on (b)(6) 2015.According to the complaint, after the procedure, the patient presented with mesh exposure at the vaginal suture line.There was no treatment given and the event has not yet resolved.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.Additional information received on december 21, 2017.On (b)(6) 2017, the patient presented with mesh exposure at the trocar passage in the vagina of less than 1 centimeter.No treatment was given and the event has not yet resolved.Additional information received on september 21, 2018.On (b)(6) 2017, during the follow-up visit, the patient presented a small 2mm left lateral exposure of mesh, and slight cystocele stage 1.

• Brand Name: UPHOLD LITE
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 6215219
• MDR Text Key: 63607674
• Report Number: 3005099803-2016-04001
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: K122459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/18/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 07/21/2018
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: ML00003091
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/07/2016
• Initial Date FDA Received: 12/30/2016
• Supplement Dates Manufacturer Received: 12/21/2017; 09/21/2018; 12/21/2018
• Supplement Dates FDA Received: 01/11/2018; 10/18/2018; 01/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Weight: 63