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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Prolapse (2475); Urinary Incontinence (4572)

Event Date 09/28/2020

Event Type  Injury  

Event Description

Note: this manufacturer report pertains to the first of two devices implanted during different procedures.It was reported to boston scientific corporation that an upsylon y-mesh device was implanted into the patient during a robotically assisted laparoscopic sacral colpopexy with cystoscopy procedure performed on (b)(6) 2017 for the treatment of vaginal vault prolapse.After the implant, the patient experienced mesh erosion from the sacral colpopexy and stress urinary incontinence.On (b)(6) 2020, the patient underwent a revision surgery of robotic complete excision of sacral colpopexy mesh, cystocele repair, rectocele repair, and a solyx bladder sling, and cystoscopy.During the procedure, the area of the mesh erosion was identified, and there was definitely a defect there and it went through-and-through into the posterior vaginal wall at the apex.Dissection of the mesh from the anterior and posterior vaginal wall was done very carefully and gently.The removed mesh was sent to pathology.Then a solyx sis system device was inserted and the patient was extubated and brought to recovery room in good condition.

Manufacturer Narrative

Date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2020 was chosen as a best estimate based on the date of the revision surgery.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.This event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6), (b)(6) hospital.(b)(4).Impact the removed mesh is not expected to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

Note: this manufacturer report pertains to the first of two devices implanted during different procedures.It was reported to boston scientific corporation that an upsylon y-mesh device was implanted into the patient during a robotically assisted laparoscopic sacral colpopexy with cystoscopy procedure performed on (b)(6) 2017 for the treatment of vaginal vault prolapse.After the implant, the patient experienced mesh erosion from the sacral colpopexy and stress urinary incontinence.On (b)(6) 2020, the patient underwent a revision surgery of robotic complete excision of sacral colpopexy mesh, cystocele repair, rectocele repair, and a solyx bladder sling, and cystoscopy.During the procedure, the area of the mesh erosion was identified, and there was definitely a defect there and it went through-and-through into the posterior vaginal wall at the apex.Dissection of the mesh from the anterior and posterior vaginal wall was done very carefully and gently.The removed mesh was sent to pathology.Then a solyx bladder sling was inserted and the patient was extubated and brought to recovery room in good condition.

Manufacturer Narrative

Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2020 was chosen as a 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 implant surgeon is: (b)(4).Block h6: patient code e2006 captures the reportable event of mesh erosion.Impact code f1905 captures the reportable event of revision surgery.Block h10: the removed mesh is not expected to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Block h11: block a2 has been updated from (b)(6) 1980, to (b)(6) 1960.Block d1 has been corrected from "colpassist" to "upsylon".

• Brand Name: COLPASSIST
• Type of Device: 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 ; 5086834015
• MDR Report Key: 13789778
• MDR Text Key: 288116970
• Report Number: 3005099803-2022-01290
• Device Sequence Number: 1
• Product Code: KOH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122794
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/30/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/24/2024
• 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: 60 YR
• Patient Sex: Female