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); Micturition Urgency (1871); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Urinary Frequency (2275); Hematuria (2558); Dysuria (2684); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 05/01/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2013, implant date, as no event date was reported.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(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 vaginal support system device was implanted into the patient during a procedure performed on (b)(6) 2013.As reported by the patient's attorney, the patient experienced an unknown injury.

Event Description

It was reported to boston scientific corporation that an uphold vaginal support system device was implanted into the patient during a procedure performed on (b)(6) 2013.As reported by the patient's attorney, the patient started seeing a physician in (b)(6) 2019 due to symptoms.It was reported that after the implantation, the patient experienced erosion of the sling into the bladder and urinary retention with recurrent urinary tract infections, incomplete bladder emptying, hematuria, burning sensation when urinating, pelvic and vaginal pain, overactive bladder, frequent urination and incontinence.Consequently, on (b)(6) 2020, the implanted sling was completely removed.The patient tolerated the procedure well and transferred to recovery room in good condition.

Manufacturer Narrative

Additional information: blocks b3: date of event, d6b: explant date and h6: patient codes and impact codes.Block b3 date of event: the exact event onset date is unknown; however, it was reported that the patient started seeing a physician in (b)(6) 2019 due to symptoms.Therefore, the event date has been approximated to (b)(6) 2019.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 mesh removal surgeon is: (b)(6).Block h6: patient codes e2006, e1309, e1310, e1302, e1301 and e2330 capture the reportable events of erosion, urinary retention, uti, hematuria, dysuria and pain.Impact code f1903 captures the reportable event of complete sling removal.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 failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• 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): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 11604210
• MDR Text Key: 243678852
• Report Number: 3005099803-2021-01343
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/09/2022

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 Model Number: M0068317080
• Device Catalogue Number: 831-708
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/04/2021
• Initial Date FDA Received: 04/01/2021
• Supplement Dates Manufacturer Received: 01/12/2022
• Supplement Dates FDA Received: 02/09/2022
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 79 KG