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

Model Number M0068317080

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

Patient Problems Erosion (1750); Inflammation (1932); Laceration(s) (1946)

Event Date 08/14/2018

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an uphold vaginal support system was implanted into the patient during a sacrospinous ligament fixation, anterior compartment anterior repair with graft placement, suburethral sling, cystoscopy procedure performed on (b)(6), 2011 for the treatment of vaginal wall prolapse, symptomatic cystocele and stress urinary incontinence.There were no complications during the implant procedure.On (b)(6), 2018, the patient underwent a revision procedure due to a diagnosis of postmenopausal vaginal mesh erosion.The procedure consisted of 1.Examination under anesthesia, 2.Excision of vaginal mesh erosion approximately 3 x 3 cm, and 3.Complex closure and imbrication of vaginal cuff.During the procedure, examination under anesthesia revealed at the vaginal apex had a significant laceration approximately 3 x 3 cm.There was also mesh erosion present in this area.A small amount of inflammatory response was noted as well.The area was infiltrated with marcaine solution and subsequently incised in elliptical fashion and the tissue in mesh were subsequently removed without difficulty.Good hemostasis was noted.No evidence of injury to surrounding structures such as bowel or bladder.The vaginal cuff was then closed with an imbricating layer of 2-0 vicryl ligature in a running locking fashion.Retention sutures of 2-0 vicryl ligature in a vertical mattress fashion was performed totaling 4 sutures in addition.The vaginal cuff was then irrigated and noted to be hemostatic.Vaginal packing was subsequently placed to be discontinued at home.The patient was then awoken and went to recovery room in stable condition.She was noted to have tolerated the procedure well.

Manufacturer Narrative

The exact event onset date is unknown.The provided event date of (b)(6), 2018 was chosen as a best estimate based on the date of the mesh revision procedure.This event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Revision procedure performed by same surgeon, dr.Kent childs at: (b)(6).(b)(4).

• Brand Name: UPHOLD VAGINAL SUPPORT SYSTEM
• 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: 15392184
• MDR Text Key: 299580745
• Report Number: 3005099803-2022-05186
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/09/2022

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: 06/30/2014
• Device Model Number: M0068317080
• Device Catalogue Number: 831-708
• Device Lot Number: ML00000192
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/11/2022
• Initial Date FDA Received: 09/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2011
• 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