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 Abdominal Pain (1685); Anemia (1706); Diarrhea (1811); Hematoma (1884); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Urinary Retention (2119)

Event Date 12/20/2012

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an uphold vaginal support system device was implanted into the patient during an anterior and posterior vaginal repair + suspension using mesh + cystoscopy procedure performed on (b)(6) 2012 for the treatment of severe cystocele, moderate rectocele and vault prolapse.Postoperatively, the patient developed atypical chest pain and diagnostics showed intermediate risk of pulmonary thromboembolism (pe).She was started on anticoagulants.The patient then developed urinary retention, pelvic pain and lower abdominal pain.A ct scan of abdomen and pelvis on (b)(6) 2012 revealed an enlarging or bleeding pelvic hematoma which measured 85x80 mm with a height of 83 mm.Anticoagulants were stopped, and ctpa was performed and was negative for pe.The patient hb was 85 and she was transfused with 2 units of packed red blood cells.The pelvic hematoma became infected as indicated by rising white cell count.The hematoma was drained transvaginally and she was treated with iv antibiotics and recovered well.She also had diarrhea while in hospital, but clostridium difficile toxin was negative, and it settled down over the following days.There was a finding of bowel wall thickening at the descending colon.The enhancing bowel wall measures approximately 4 mm in thickness and there was adjacent inflammatory change.The patient was to follow up for a colonoscopy.

Manufacturer Narrative

The provided event date of (b)(6) 2012 was chosen as a best estimate based on the date the symptom was noted via a ct scan.This complaint was received as litigation from a legal source in australia.The implant surgeon is: dr.(b)(6).Imdrf patient codes e1309, e0505, e2330, e1002, e1906 and e0301 capture the reportable events of urinary retention, pelvic hematoma, pelvic pain, abdominal pain, hematoma became infected and anemia - hb was low enough to require blood transfusion.Imdrf impact code f1901, f2302 and f08 capture the reportable events of evacuation of pelvic hematoma, blood transfusion and prolonged hospitalization.

• 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: 16380664
• MDR Text Key: 309596054
• Report Number: 3005099803-2023-00490
• 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: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/15/2023

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: 07/31/2015
• Device Model Number: M0068317080
• Device Catalogue Number: 831-708
• Device Lot Number: ML00000800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/17/2023
• Initial Date FDA Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female