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 Problems Hemorrhage/Bleeding (1888); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Unspecified Tissue Injury (4559)

Event Date 11/07/2014

Event Type  Injury  

Manufacturer Narrative

Date of the adverse event was approximated to (b)(6) 2014, implant date, as no event date was reported.This event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).(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 Description

It was reported to boston scientific corporation that an uphold (tm) lite with capio slim was implanted during an anterior mesh uphold lite and cystoscopy procedure performed on (b)(6) 2014 to treat anterior vaginal prolapse.As reported by the patient's attorney, post-procedure, the patient experienced pain and was given with analgesia.Moreover, she made a good recovery.On (b)(6) 2014, the patient experienced some minor symptoms of stress incontinence.A tube of ovestin cream was given.The patient was not taking vagifem as this causes tenderness upon insertion.On examination, there was some tenderness and there was a raw area at the anterior vaginal wall.On (b)(6) 2015, the patient still had decrease libido, and hot flushes came back just prior to intimacy.She was given with ditropan 5mg daily for her dry eyes and mouth.On (b)(6) 2015, the patient experienced pain, infection and bleeding with no improvement.

Manufacturer Narrative

Correction to blocks b5, b7 and h6 - the event of infection was moved to patient's history as it was in relation to her psoriasis/ongoing fingernail issues, and added tissue damage to capture "raw area" as one of the patient's symptoms.Moreover, hemorrhage was used to capture "contact bleeding".Block b3: date of the adverse event was approximated to (b)(6) 2014, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).Block h6: patient codes e2330 and e2015 capture the reportable events of pain and raw area respectively.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: 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 Description

It was reported to boston scientific corporation that an uphold (tm) lite with capio slim was implanted during an anterior mesh uphold lite and cystoscopy procedure performed on (b)(6) 2014 to treat anterior vaginal prolapse.As reported by the patient's attorney, post-procedure, the patient experienced pain and was given with analgesia.Moreover, she made a good recovery.On (b)(6) 2014, the patient experienced some minor symptoms of stress incontinence.A tube of ovestin cream was given.The patient was not taking vagifem as this causes tenderness upon insertion.On examination, there was some tenderness and there was a raw area with a contact bleeding at the anterior vaginal wall.On (b)(6) 2015, the patient still had decrease libido, and hot flushes came back just prior to intimacy.She was given with ditropan 5mg daily for her dry eyes and mouth.

• 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: 11171416
• MDR Text Key: 226839783
• Report Number: 3005099803-2021-00113
• Device Sequence Number: 1
• Product Code: OTP
• UDI-Device Identifier: 08714729839200
• UDI-Public: 08714729839200
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: ML00002350
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR