MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPSYLON; MESH, SURGICAL, SYNTHETIC

Model Number	M0068318200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ischemia (1942); Necrosis (1971); Pain (1994); Obstruction/Occlusion (2422)
Date of Event	11/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an upsylon ymesh device was implanted during a robotic-assisted laparoscopic sacral colpopexy with anterior, posterior repair and enterocele repair and cystoscopy procedure performed on (b)(6) 2016.On (b)(6) 2021, the patient was taken to the operating room urgently for exploratory laparotomy as the patient had crampy abdominal pain and acute surgical abdomen.It was found out that the patient had a closed loop bowel obstruction which was caused by mesh placed for a sacro colpopexy and the loop of bowel got caught underneath the mesh.Specifically, it was the small bowel (ileum) that was obstructed.There was also a gangrene of the ileum resulting in the need for bowel resection (approx.30 cm of small bowel removed).The patient tolerated the procedure well and was taken to the recovery room in satisfactory condition.
Additional Manufacturer Narrative
Block b3: the exact event onset date is unknown.The provided event date of november 19, 2021, was chosen as the best estimate based on the operation date.Block h6: imdrf patient code e2328 captures the reportable event of obstruction.Imdrf patient code e0509 captures the reportable event of ischemia.Imdrf patient code e2327 captures the reportable event of necrosis.Imdrf impact code f1901 captures the reportable event of lysis of adhesions.
Event or Problem Description
It was reported to boston scientific corporation that an upsylony mesh device was implanted during a robotic-assisted laparoscopic sacral colpopexy with anterior, posterior repair and enterocele repair and cystoscopy procedure performed on (b)(6) 2016.On (b)(6) 2021, the patient was taken to the operating room urgently for exploratory laparotomy as the patient had crampy abdominal pain and acute surgical abdomen.It was found out that the patient had a closed loop bowel obstruction which was caused by mesh placed for a sacro colpopexy and the loop of bowel got caught underneath the mesh.Specifically, it was the small bowel (ileum) that was obstructed.There was also a gangrene of the ileum resulting in the need for bowel resection (approx.30 cm of small bowel removed).The patient tolerated the procedure well and was taken to the recovery room in satisfactory condition.
Additional Manufacturer Narrative
Correction to blocks h6 (patient codes) and h10.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 operation date.Block h6: imdrf patient code e2328 captures the reportable event of obstruction.Imdrf patient code e0509 captures the reportable event of ischemia.Imdrf patient code e2330 captures the reportable event of pain requiring medical treatment.Imdrf impact code f1901 captures the reportable event of exploratory laparotomy, lysis of adhesions and bowel resection.

• Brand Name: UPSYLON
• Common Device Name: MESH, SURGICAL, SYNTHETIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): PROXY BIOMEDICAL LIMITED; coilleach spiddal; galway ; EI
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19071729
• Report Number: 2124215-2024-19094
• Device Sequence Number: 15178744
• Product Code: OTO
• UDI-Device Identifier: 08714729839217
• UDI-Public: 08714729839217
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K122794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: M0068318200
• Device Catalogue Number: 831-820
• Device Lot Number: C002890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/12/2024
• Supplement Date Received by Manufacturer: 04/22/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female