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 Adhesion(s) (1695); Pain (1994)

Event Date 09/22/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2020 was chosen as a best estimate based on the date of mesh excision surgery.This event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).(b)(6) hospital.(b)(6).Mesh excision surgeon is: dr.(b)(6).(b)(6) medical center (b)(6).(b)(4).The removed mesh is not expected to be returned for evaluation; therefore, a problem 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 device was implanted into the patient during a lap lso (laparoscopic left salpingo-oophorectomy) + uphold procedure + posterior repair with biologic graft + cystoscopy procedure performed on (b)(6) 2018 for the treatment of cystocele, rectocele and stress urinary incontinence.After the implant, the patient had experienced pelvic pain and labial adhesions.On (b)(6) 2020, the patient underwent a vaginal mesh excision, anterior repair, separation of labial adhesions and cystoscopy procedure.On initial exam, the patient had a banded apical mesh.The sling appeared to be laying flat and off tension.There were labial and clitoral adhesions creating skin banding.The mesh was sharply divided in the midline and sharp dissection was then performed to the sacrospinous ligaments bilaterally mobilizing the mesh and then excising the mesh at the base.Anterior repair was then performed using 2-0 vicryl in an imbricating manner, the vagina closed in a running fashion using 2-0 vicryl, and perineum repaired using mattress stitches of 2-0 vicryl.Cystoscopy was then performed showing no evidence of bladder or urethral injury.Then, blunt separation was used to lyse the adhesions of the periclitoral and labial area which did remove the skin banding and the skin that was covering the urethra.The patient tolerated the procedure well and was taken to recovery in stable condition.No complications reported.

Manufacturer Narrative

Correction: blocks b5, b7 and h6: patient code.Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2020 was chosen as a best estimate based on the date of mesh excision surgery.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6); (b)(6); hospital; (b)(6).Mesh excision surgeon is: dr.(b)(6); (b)(6) medical center; (b)(6).Block h6: patient codes of e2330 capture the reportable events of pelvic pain.Impact code f1905 capture the reportable event of mesh excision surgery.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the removed mesh is not expected to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

Note: this manufacturer report pertains to the first of two devices used during the same procedure.It was reported to boston scientific corporation that an uphold lite device was implanted into the patient during a lap lso (laparoscopic left salpingo-oophorectomy) + uphold procedure + posterior repair with biologic graft (repliform) + retropubic suburethral sling (advantage fit) + cystoscopy procedure performed on (b)(6) 2018 for the treatment of cystocele, rectocele and stress urinary incontinence.There were no complications during the implant procedure and the patient was in stable condition following the procedure.After the implant, the patient had experienced pelvic pain and labial adhesions.On (b)(6) 2020, the patient underwent a vaginal mesh excision, anterior repair, separation of labial adhesions and cystoscopy procedure.On initial exam, the patient had a banded apical mesh.The sling appeared to be laying flat and off tension.There were labial and clitoral adhesions creating skin banding.The anterior mesh (uphold) was sharply divided at the midline and sharp dissection was then performed to the sacrospinous ligaments bilaterally mobilizing the mesh and then excising the mesh at the base.Anterior repair was then performed using 2-0 vicryl in an imbricating manner, the vagina closed in a running fashion using 2-0 vicryl, and perineum repaired using mattress stitches of 2-0 vicryl.Cystoscopy was then performed showing no evidence of bladder or urethral injury.Then, blunt separation was used to lyse the adhesions of the periclitoral and labial area which did remove the skin banding and the skin that was covering the urethra.The patient tolerated the procedure well and was taken to recovery in stable condition.No complications reported.

• 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
• Manufacturer (Section G): FREUDENBERG MEDICAL MIS INC; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15095205
• MDR Text Key: 296502401
• Report Number: 3005099803-2022-04054
• Device Sequence Number: 1
• Product Code: OTP
• UDI-Device Identifier: 08714729839200
• UDI-Public: 08714729839200
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/27/2022

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: 01/31/2020
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: 0000054926
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/29/2022
• Initial Date FDA Received: 07/25/2022
• Supplement Dates Manufacturer Received: 07/26/2022
• Supplement Dates FDA Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female