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

Device Problem Defective Device (2588)

Patient Problems Pain (1994); Insufficient Information (4580)

Event Date 07/13/2018

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a pinnacle posterior pelvic floor repair kit was used during a posterior vaginal repair and sacrospinous bilateral vaginal vault suspension with insertion of pinnacle posterior mesh and cystoscopy with hydrodistention along with urethral dilation (hydrodistention to 800 cc) procedures performed on (b)(6) 2011 to treat a patient with rectocele, urinary retention, vaginal prolapse and urethral syndrome as well as very mild chronic cystitis.On (b)(6)2018, the patient was experiencing pelvic pain.On initial examination, the patient had an extremely irregular vagina with large masses of bunched mesh palpable on vaginal and rectal examination.There was no exposure of the mesh on the vaginal side or the rectal side.Posterior mesh excision and posterior repair with perineoplasty procedures were then performed.The patient was taken to the operating room where general anesthesia was administered and found to be adequate.The patient was prepared for surgery.A transurethral foley catheter was placed and set to drainage.The lone star was used for visualization.After injecting 1% lidocaine with epinephrine, a vertical incision was then made over the perineum.The vagina was then mobilized all the way above the level of the posterior mesh.With a finger in the rectum, the physician mobilized the mesh from the rectum.The physician then followed the right sacrospinous arm to the level of the sacrospinous ligament.It was then cut near the sacrospinous ligament.The physician then mobilized the mesh across the midline to the left sacrospinous ligament where again the physician cut the left sacrospinous ligament arm near the sacrospinous ligament.The physician then mobilized the remainder of the mesh and handed the mesh off.Hemostasis was then achieved.The physician then performed a posterior repair using #2-0 vicryl in imbricating manner to the level of the perineal body.The vaginal epithelium was left intact and was closed in a running fashion using #2-0 vicryl after placing surgeon flow in the bilateral perirectal spaces.The bulbocavernosus muscles were brought together in the midline.The superficial transverse perineal muscles were brought together midline.Hemostasis was then noted.A vaginal packing was placed.The physician was able to remove the entire posterior mesh intact including most of both arms.At the end of the procedure, there was excellent support of the posterior vaginal wall.Rectal examination confirmed no rectal injury.The patient tolerated the procedure well and there were no patient complications noted at the conclusion of the procedure.

Manufacturer Narrative

The complainant was unable to provide the upn and lot number of the suspect device.Therefore, the manufacture and expiration dates are unknown.This event was reported by the patient's legal representation.The implant surgeon is: (b)(6).The explant surgeon is: (b)(6).(b)(4).The complaint device is not expected to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• 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: 15202914
• MDR Text Key: 297681713
• Report Number: 3005099803-2022-04135
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/13/2022
• 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): Other; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female