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

Model Number M0068402400

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

Patient Problems Bacterial Infection (1735); Erosion (1750); Hemorrhage/Bleeding (1888); Prolapse (2475)

Event Date 09/09/2021

Event Type  Injury  

Manufacturer Narrative

Block e1: this event was reported by the patient's legal representation.The implanting physicians are: dr.(b)(6) (surgeon), and dr.(b)(6) (assistant).(b)(6) hospital.(b)(6).Phone: (b)(6).Block h6: the following imdrh patient codes and impact code capture the reportable events of: e2333- prolapse.E2006- erosion and extrusion.E190- bacterial infection.F1905- device revision or replacement.

Event Description

It was reported to boston scientific corporation that a polyform synthetic mesh was implanted into the patient during abdominal supracervical hysterectomy, sacrocervicopexy with mesh, posterior repair, perineorrhaphy, and cystoscopy procedure on (b)(6) 2010, for the treatment of uterine prolapse and rectocele.After the procedure, the patient was awakened from anesthesia without complication and was taken to the recovery room in stable condition.On (b)(6) 2021, the patient underwent trachelectomy and revision of vaginal graft with cystoscopy procedure for the treatment of eroded vaginal mesh and prolapse of vaginal vault after hysterectomy.Purulent discharge and bleeding from the cervix were noted at the start of the case.An estimated blood loss of 50 cubic centimeter was reported.During trachelectomy, unequivocal evidence of infected mesh was observed.Mesh was removed in its entirety from the vagina without difficulty.Inspection of the cervical os demonstrated clear evidence of mesh protruding from the cervical os, consistent with a mesh extrusion.Cystourethroscopy was performed without difficulty.Unequivocal flow was seen from both ureteral orifice ease.There was no evidence of masses, lesions, polyps, suture, foreign bodies or any other abnormality in the bladder at the end of the case.The patient did well postoperatively and was discharged home.The patient was seen on (b)(6) 2021, for her 6-week post-operative evaluation.The patient's bleeding and discharges have been resolved.The patient reported normal bowel movement, was able to empty the bladder well, had no fever shakes or chills, no protrusion felt, and had recovered well.A physical examination was performed, and the patient incision was well healed.There is still fullness at the vaginal apex, but there is minimal pain and no evidence of cellulitis.The overall impression is that the patient recovered well from her trachelectomy and revision of the eroded mesh.The patient was healing and showed no evidence of recurrent mesh erosion.The patient was advised to follow up two months later to re-evaluate her prolapse.

• Brand Name: POLYFORM SYNTHETIC MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17770388
• MDR Text Key: 323692173
• Report Number: 3005099803-2023-04918
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2012
• Device Model Number: M0068402400
• Device Catalogue Number: 840-240
• Device Lot Number: C000908
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2009
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female