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

Model Number M0068402400

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

Patient Problems Erosion (1750); Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Ischemia (1942); Pain (1994); Tissue Damage (2104); Urinary Retention (2119); Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

(b)(4).These cases were reported during the 18th annual meeting of the (b)(6).The complainant indicated that the device will not 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.(b)(4).

Event Description

It was reported to boston scientific that polyform graft materials were used during an unspecified number of mesh implantation procedures from (b)(6) 2014 to (b)(6) 2016.According to the complainant, the following complications occurred related to the implantation procedure with the polyform graft materials: there were nine cases of bladder damage; five cases of rectum damage; four cases of hemostasis difficulty which required treatment using interventional radiology (ivr); six cases of hydronephrosis; three cases of pain after the procedure; twenty cases of mesh exposure from the vaginal wall; one case of mesh exposure from the rectum; one case of mesh exposure from the bladder; five cases of mesh infection; and one case of non-specific complication, including stroke and hepatic infarction.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.

Event Description

It was reported to boston scientific that polyform graft materials were used during an unspecified number of mesh implantation procedures from april 2014 to march 2016.According to the complainant, the following complications occurred related to the implantation procedure with the polyform graft materials: there were nine cases of bladder damage; five cases of rectum damage; four cases of hemostasis difficulty which required treatment using interventional radiology (ivr); six cases of hydronephrosis; three cases of pain after the procedure; twenty cases of mesh exposure from the vaginal wall; one case of mesh exposure from the rectum; one case of mesh exposure from the bladder; five cases of mesh infection; and one case of non-specific complication, including stroke and hepatic infarction.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.Additional information received on august 15, 2017.Per the 2017 annual meeting of the japanese society of female pelvic floor medicine (jfpfm), the following complications related to the implantation of polyform were reported for the time period of june 2014 to june 2017: there were thirteen cases of bladder damage, eight cases of rectum damage, six cases of hemostasis difficulty which required treatment using interventional radiology (ivr), six cases of hydronephrosis, three cases of pain after the procedure, forty-two cases of mesh exposure from the vaginal wall, two cases of mesh exposure from the bladder, five cases of mesh infection, and one case of non-specific complication (stroke, hepatic infarction, death).Additional information july 22, 2018.Per the 2018 annual meeting of the japanese society of female pelvic floor medicine (jfpfm), the following complications related to the implantation of polyform were reported for the time period of june 2014 to june 2018: there were eleven cases of bladder damage, six cases of ureter damage, eight cases of rectum damage, ten cases of hemostasis difficulty which required treatment using interventional radiology (ivr), three cases of pain after the procedure, forty-one cases of mesh exposure from the vaginal wall, two cases of mesh exposure from the rectum, two cases of mesh exposure from the bladder, seven cases of mesh infection, one case of urinary retention, and one case of non-specific complication (stroke, hepatic infarction, death).

Manufacturer Narrative

Patient problem code 2119 added based on the additional information that there was one case of urinary retention as of june 2018.

• Brand Name: POLYFORM SYNTHETIC MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 5773758
• MDR Text Key: 48918040
• Report Number: 3005099803-2016-01941
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 06/12/2016

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 Model Number: M0068402400
• Device Catalogue Number: 840-240
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/12/2016
• Initial Date FDA Received: 07/06/2016
• Supplement Dates Manufacturer Received: 08/15/2017
• Supplement Dates FDA Received: 08/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention