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

Model Number M0068318150

Device Problem Material Deformation (2976)

Patient Problems Fistula (1862); Hemorrhage/Bleeding (1888); Pain (1994); Pneumonia (2011); Urinary Tract Infection (2120); Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

Date of event: the exact event onset date is unknown; however, it was reported that the problem of pain began during 2017 and 2018.Therefore, event date has been approximated to (b)(6)2017.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Report source: tga device incident report reference no (b)(4); submitted to tga (therapeutic goods administration) by the patient.(b)(4).The removed mesh 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 Description

It was reported that a pinnacle lite device was implanted into the patient during a procedure performed in 2012 to treat prolapsed vaginal wall.According to the patient, the implant improved her condition for several years.However, the mesh shrank and hardened after some time.During 2017 and 2018, the issue of pain began and became worse over time.In (b)(6) 2018, the patient had mesh removal surgery which resulted in hemorrhage and two developing fistulas.Due to this, the patient was scheduled for an ostomy bag insertion in late (b)(6) 2018 as a reversible operation.However, during her hospital stay, the patient developed heart failure, pneumonia and fluid issues and was considered not suitable for a reversal operation as the fistulas were not likely to improve.The patient added that she has continuous uti and is taking antibiotic.

• Brand Name: PINNACLE 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12511169
• MDR Text Key: 272643166
• Report Number: 3005099803-2021-04859
• Device Sequence Number: 1
• Product Code: OTP
• 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,consum
• Type of Report: Initial
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M0068318150
• Device Catalogue Number: 831-815
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2021
• 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: 87 YR