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

Device Problem Material Twisted/Bent (2981)

Patient Problems Abdominal Pain (1685); Erosion (1750); Granuloma (1876); Inflammation (1932); Pain (1994); Scar Tissue (2060); Obstruction/Occlusion (2422); Dysuria (2684); Dyspareunia (4505); Insufficient Information (4580)

Event Date 02/23/2009

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(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.The voluntary user medwatch number is mw5103346.

Event Description

Note: this manufacturer report pertains to the first of two devices used during the same procedure.It was reported to boston scientific corporation that pinnacle mesh and advantage fit system devices were implanted into the patient during a vaginal prolapse and bladder sling suspension procedure performed on (b)(6) 2009.From the time the patient woke up following procedure, the patient experienced severe pain.Discharged from hospital to home but unable to take care of herself due to pain.Several months later, the patient tried to have relations or to be intimate with husband but unable to do so due to unbearable pain.Had multiple doctor visits over the years for severe abdominal pain and unable to urinate properly.By 2019, patient saw her primary physician and uro/gyn again for severe pain and planned to have the mesh removed.On (b)(6) 2020, the patient subsequently underwent bilateral paravaginal dissection; bilateral pararectal dissection; removal of pinnacle and advantage sling; urethral lysis; and anterior and posterior colporrhaphy.Post operative diagnosis showed urethral scarring, foreign body in vagina and exposed mesh.During the surgery, it was discovered that there were severe scarring, eroded pinnacle fibers, the sling was in the right obturator muscle, bladder wall and lateral to the rectus muscle.The pinnacle mesh was rolled or twisted and folded on the left.Sections of the pinnacle mesh and advantage fit mesh showed fibrosis, chronic inflammation, and foreign body type giant cell reaction.The patient also developed sjogren's disease and still experienced pain and dyspareunia.Patient had multiple diagnostics for the course of 11 years.

• Brand Name: PINNACLE
• 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: 12545437
• MDR Text Key: 273736248
• Report Number: 3005099803-2021-05022
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial
• Report Date: 09/29/2021

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/03/2021
• Initial Date FDA Received: 09/29/2021
• 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): Hospitalization; Required Intervention; Disability