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 Adhesion(s) (1695); Scar Tissue (2060); Prolapse (2475); Urinary Incontinence (4572)

Event Date 12/10/2021

Event Type  Injury  

Event Description

Note: this manufacturer report pertains to the first of three devices used in separate procedures.It was reported to boston scientific corporation that an uphold vaginal support system device was implanted during an anterior colporrhaphy and sacrospinous ligament fixation, paravaginal defect repair with uphold, video cystoscopy, and posterior colporrhaphy in traditional fashion procedure performed on (b)(6) 2009, for the treatment of pelvic floor prolapse and incomplete emptying.On (b)(6) 2021, the patient underwent a robotic sacro colpopexy with a trans obturator sling and posterior repair due to vaginal vault prolapse, stress urinary incontinence, and rectocele.Although the patient was 75 years old, it was noted that she led a very active, robust lifestyle.During the procedure, the physician noted that the patient had significant adhesions in the small bowel and large bowel in the pelvis that were very adherent and dense.Additionally, the plane between the rectum and underlying vagina could not be easily developed due to dense scarring and adhesions between the two structures.When the vaginal mesh was identified, it was nearly impossible to dissect.The physician was able to dissect a portion of the system; however, it was noted that dissecting further could increase the risks of injury.The tail of the mesh was then sutured to the sacral promontory.The tape was placed against the passer and delivered through the inguinal crease.The tension band was cut, and the sleeves were removed.Cystoscopy confirmed the case was completed without any bladder or urethral injuries.After closure, the physician did not consider it necessary to open the patient back up to redo the promontory anastomosis on this basis alone.The patient tolerated the procedure well without complications.On (b)(6) 2021, the patient was diagnosed with an exposed trans obturator mesh in the bilateral groin.She then underwent a groin exploration with excision of exposed mesh, a vaginal exam under anesthesia, and cystourethroscopy.During the procedure, it was noted that the urethra was intact and there were no signs of infection.The mesh was dissected into the subcutaneous fat, collected, and sent for gross pathologic analysis.The patient was awakened from anesthesia, transferred to a cot, and taken to the recovery room in good condition.

Manufacturer Narrative

Manufacturer reports number 3005099803-2023-04891 and 3005099803-2023-04892 are related to the same patient.Relevant information for each device will be captured accordingly.Block b3: the exact event onset date is unknown.The provided event date of (b)(6) 2021, was chosen as the best estimate based on the date of the revision surgery.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.The implanting physician is: dr.(b)(6).Block h6: imdrf patient code e2333 captures the reportable event of vaginal vault prolapse and rectocele.Imdrf patient code e232402 captures the reportable event of stress urinary incontinence.Imdrf patient code e1715 captures the reportable event of scarring.Imdrf patient code e2101 captures the reportable event of significant adhesions with the small and large bowel in the pelvis that were very adherent and dense.Imdrf impact code a24 captures the reportable event of y-mesh implantation.

• 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: 17735848
• MDR Text Key: 323270907
• Report Number: 3005099803-2023-04889
• 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: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M0068317080
• Device Catalogue Number: 831-708
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Race: White