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

Model Number	M0068402590
Medical Device Problem Codes	Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Erosion (1750); Pain (1994); Scar Tissue (2060); Dyspareunia (4505)
Date of Event	11/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The exact event onset date is unknown.The provided event date of (b)(6) 2019 was chosen as a best estimate based on the date of the revision surgery.This event was reported by the patient's legal representation.Device was implanted by: (b)(6).Revision surgery was performed by: dr.(b)(6).(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 or Problem Description
It was reported to boston scientific corporation that the patient was diagnosed with uterine prolapse stage 3.On (b)(6) 2019, patient was implanted with a polyform mesh during a davinci sacrocolpohysteropexy, posterior repair and cystoscopy procedure.On (b)(6) 2019, the patient underwent removal of abdominal polyform, abdominal hysterectomy, bilateral salpingectomy, removal of posterior polyform mesh, posterior colporrhaphy and colpoperineorrhaphy procedure due to mesh in the abdomen from the previous abdominal hysteropexy, vaginal mesh cording in the posterior cul-de-sac from the hysteropexy and extension to the perineum along the entire posterior segment over the rectum.Patient was also presented with vaginal pain, pain with intercourse and foreign material in the vagina.During the procedure, it was found that there was some scar tissue from the mesh as well as adhesions of the mesh to the bladder, around and through the right and left broad ligaments.There were also bowel adhesions to the mesh as well as "bunched" folded mesh in the cul-de-sac and posterior vaginal walls.The mesh was removed without injury to the bowel or bladder.Procedure was completed with an estimated blood loss of 300cc.Patient tolerated procedure well in excellent condition.
Additional Manufacturer Narrative
Correction to blocks b5 and h6 - the event of material twisted/bent was coded to capture the "bunched" folded mesh in the in the cul-de-sac and posterior vaginal walls.Also, erosion was added to better capture the event of mesh in the abdomen.Block b3: the exact event onset date is unknown.The provided event date of (b)(6) 2019 was chosen as a best estimate based on the date of the revision surgery.Block e1: this event was reported by the patient's legal representation.Device was implanted by: dr.(b)(6).Revision surgery was performed by: dr.(b)(6).Block h6: patient codes e1715, e2006, e2101, e2330, and e1405 capture the reportable events of scar tissue, mesh in the abdomen and vaginal erosion, adhesions, vaginal pain and painful intercourse.Impact code f19 capture the reportable event of additional surgery.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: 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 or Problem Description
It was reported to boston scientific corporation that the patient was diagnosed with uterine prolapse stage 3.On (b)(6) 2019, patient was implanted with a polyform mesh during a davinci sacrocolpohysteropexy, posterior repair and cystoscopy procedure.On (b)(6) 2019, the patient underwent removal of abdominal polyform, abdominal hysterectomy, bilateral salpingectomy, removal of posterior polyform mesh, posterior colporrhaphy and colpoperineorrhaphy procedure due to mesh in the abdomen from the previous abdominal hysteropexy, vaginal mesh cording in the posterior cul-de-sac from the hysteropexy and extension to the perineum along the entire posterior segment over the rectum.Patient was also presented with vaginal pain, pain with intercourse and foreign material in the vagina.During the procedure, it was found that there was some scar tissue from the mesh as well as adhesions of the mesh to the bladder, around and through the right and left broad ligaments.There were also bowel adhesions to the mesh as well as "bunched" folded mesh in the cul-de-sac and posterior vaginal walls.The mesh was removed without injury to the bowel or bladder.Procedure was completed with an estimated blood loss of 300cc.Patient tolerated procedure well in excellent condition.

• Brand Name: POLYFORM
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11419106
• Report Number: 3005099803-2021-00939
• Device Sequence Number: 2854781
• Product Code: OTO
• UDI-Device Identifier: 08714729845256
• UDI-Public: 08714729845256
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K051245
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2021

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: 07/31/2021
• Device Model Number: M0068402590
• Device Catalogue Number: 72850
• Device Lot Number: C003749
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 03/05/2021
• Supplement Report FDA Received Date: 04/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 23 YR