MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPHOLD VAGINAL SUPPORT SYSTEM; 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 Tissue Damage (2104); Obstruction/Occlusion (2422)

Event Date 10/24/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4) adverse incident report reference no.(b)(4); submitted to (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¿ lite w/ capio slim was used during a uphold mesh placement procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the ureter was noticed to be kinked.It was showed shortly after "blow out lesion" in the kidney pelvis via ct urography.A ureter stent was placed and mesh was removed.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

Manufacturer Narrative

Manufacturing site: although the current manufacturing site for uphold lite is boston scientific in spencer in, the reported lot involved in this complaint was manufactured by: freudenberg medical 2301 centennial boulevard jefferson in, 47130 usa.Dkma adverse incident report reference no.(b)(4); submitted to dkma (danish medicines agency).Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.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 lite w/ capio slim was used during an uphold mesh placement procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the left ureter was noticed to be kinked, obstructing the flow of urine into the bladder.Reportedly, this could have been due to the local anesthesia.However, for safety reasons ct urography/x-ray examination of the urinary tract was performed, showing a "blow out lesion" in the kidney pelvis.The left leg of the mesh was removed the next day and the rest of the mesh remained implanted in the patient.A double j catheter was placed in the left ureter and was removed after four weeks.At the sixth month follow-up after the surgery, the patient was reportedly satisfied with the result.There were no signs of genital prolapse and no persistent problems noted.

• 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
• MDR Report Key: 7640971
• MDR Text Key: 112420499
• Report Number: 3005099803-2018-02002
• Device Sequence Number: 1
• Product Code: OTP
• UDI-Device Identifier: 08714729839200
• UDI-Public: 08714729839200
• Combination Product (y/n): N
• PMA/PMN Number: K122459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/14/2019

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: 02/29/2020
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: 00000057716
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/28/2018
• Initial Date FDA Received: 06/27/2018
• Supplement Dates Manufacturer Received: 12/17/2018
• Supplement Dates FDA Received: 01/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention