MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPHOLD LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN

Model Number M0068318170

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

Patient Problems Erosion (1750); Pain (1994); Discomfort (2330); Prolapse (2475); No Code Available (3191)

Event Date 06/11/2019

Event Type  Injury  

Manufacturer Narrative

Initial reporter: dr.(b)(6) was the physician who performed mesh removal.The implanting physician's details were not reported.(b)(4).Report source: (b)(6) reference no (b)(4); submitted to (b)(6) by the pharmacist.The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an uphold lite with capio slim device was implanted during a pelvic floor repair procedure performed on (b)(6) 2016.According to the complainant, after the procedure, the patient has experienced pain, discomfort and sensation of recurrence of prolapse.On (b)(6) 2019, after examination, an explantation of the mesh was performed due to signs of erosion.Reportedly, the patient still currently experiences pain and discomfort, and sensation of recurrent prolapse.

Event Description

It was reported to boston scientific corporation that an uphold lite with capio slim device was implanted during a pelvic floor repair procedure performed on (b)(6) 2016.According to the complainant, after the procedure, the patient has experienced pain, discomfort and sensation of recurrence of prolapse.On (b)(6) 2019, after examination, an explantation of the mesh was performed due to signs of erosion.Reportedly, the patient still currently experiences pain and discomfort, and sensation of recurrent prolapse.

Manufacturer Narrative

Block e1: dr.(b)(6) was the physician who performed mesh removal.The implanting physician's details were not reported.Blocks f10 and h6: patient codes of 1750 and 3191 capture the reportable events of erosion and mesh removal.Block g3: ansm reference no r1912920; submitted to ansm (agence nationale de securite du medicament) by the pharmacist.Block h10: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.Block h11: block d6 updated to provide the correct implant date.

• Brand Name: UPHOLD LITE
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8844286
• MDR Text Key: 152755365
• Report Number: 3005099803-2019-03800
• Device Sequence Number: 1
• Product Code: OTP
• UDI-Device Identifier: 08714729839200
• UDI-Public: 08714729839200
• Combination Product (y/n): N
• PMA/PMN Number: K122459
• 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: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/23/2018
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: ML00003332
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/31/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention