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

Model Number M0068317050

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

Patient Problems Erosion (1750); Pain (1994); Dyspareunia (4505)

Event Date 10/02/2018

Event Type  Injury  

Event Description

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2022-04592 for the associated device information.It was reported to boston scientific corporation that a solyx sis system and a pinnacle device was used during a procedure performed on (b)(6) 2009.On (b)(6) 2018, the patient experienced pelvic pain and dyspareunia in female.In addition, approximately 4 cm area of exposed apical vaginal mesh was noted.However, no evidence of abscess or infection was noted.Posterior mesh was tense at bilateral sacrospinous fixation points.The bladder appeared normal.There was no evidence of mesh, suture, or trauma to bladder.The bilateral ureteral orifices with efflux of urine was seen from both.There was no evidence of injury to the rectum noted.An excision of anterior, apical and posterior vaginal mesh and cystoscopy procedures were then performed.The patient was brought to the operating room and administered with general anesthesia.Bilateral scd's were in place.The patient was positioned for vaginal surgery with her legs placed in allen stirrups taking care to avoid any hyperextension, hyperabduction, hyperadduction or pressure points.She was then prepped and draped in a normal sterile fashion.The patient received ancef and flagyl for antibiotic prophylaxis.A foley catheter was inserted.A detailed exam was performed.The area of exposed vaginal mesh at the vaginal apex was easily visible and palpable.The lonestar retractor was placed.They addressed the anterior vaginal wall first.They injected dilute marcaine with epinephrine along the anterior vaginal wall and at the vaginal apex.They made a midline vertical incision through the vaginal epithelium with a scalpel, starting from the apex/exposed mesh, extending distally to the bladder neck.They also made an elliptical incision around the exposed vaginal mesh at the apex.The provided fresh edges for closure in a "t-shaped" fashion.The endopelvic fascia was then carefully dissected laterally from the overlaying vaginal epithelium until good, healthy, well incorporated tissue was encountered.The mesh was bisected in the midline.The mesh was carefully separated from the underlying bladder mucosa and endopelvic fascia.The anterior mesh was separated from the apical/posterior component of the mesh.The lateral borders of the mesh material were identified and removed at the endopelvic fascia at the arms of the mesh as far lateral as possible.Theos removed all the anterior vaginal mesh material easily visible and palpable to the arms and deeper tissue.The apical vaginal mesh was then grasped, dissected from the underlying endopelvic fascia and its attachment arms were followed laterally down toward the sacrospinous ligaments as far as possible.The arms were excised.This exposed all of the apical/posterior vaginal mesh.Spot hemostasis was obtained.Sutures of #2-0 vicryl were also used for deep hemostasis where needed on the patient's left side.There was a tunnel toward the sacrospinous that had venous bleeding.Floseal was placed and held under pressure with gelfoam as well.The area appeared hemostatic.The vaginal wall was closed with a #2-0 vicryl.The area was held under pressure with vaginal packing and estrogen vaginal cream.The patient tolerated the procedure well.All counts are correct.The patient was taken to the recovery room in stable condition.

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2018, revision procedure date, as no event date was reported.Initial reporter name and address: this event was reported by the patient's legal representation.The implant 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 PELVIC FLOOR REPAIR KITS
• 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): FREUDENBERG MEDICAL MIS INC; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15328948
• MDR Text Key: 298995115
• Report Number: 3005099803-2022-04593
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071957
• 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: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2009
• Device Model Number: M0068317050
• Device Catalogue Number: 831-705
• Device Lot Number: 0ML8100201
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2008
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female