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

Model Number M0068317010

Device Problems Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Pain (1994); Injury (2348); Dyspareunia (4505); Urinary Incontinence (4572)

Event Date 09/04/2015

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2011, implant date, as no event date was reported.(b)(6).(b)(4).The complaint device 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 to boston scientific corporation that a pinnacle duet pelvic floor repair kit was implanted during a procedure performed on (b)(6) 2011.As reported by the patient's attorney, the patient has experienced an unspecified injury.Boston scientific has been unable to obtain additional information regarding the event to date.

Event Description

It was reported to boston scientific corporation that a pinnacle duet pelvic floor repair kit was implanted during a procedure performed on (b)(6) 2011.As reported by the patient's attorney, the patient has experienced an unspecified injury.Boston scientific has been unable to obtain additional information regarding the event to date.Additional information received on december 8, 2022.The procedures performed on (b)(6) 2011 were pinnacle implant, anterior and posterior repair to treat a patient with cystocele, vault prolapse and rectocele.On (b)(6) 2015, the patient was experiencing vaginal pain due to a contracted mesh, dyspareunia, stress urinary incontinence.The patient underwent a laparoscopic adhesiolysis, laparoscopic excision of vaginal mesh, tension free vaginal tape procedure, and cystoscopy procedures.At surgery, a palmer's point entry was utilized in the left upper quadrant, and three additional 5mm trocars were applied.There were dense intra-abdominal adhesions present on the anterior abdominal wall, which were mobilized for greater than forty-five (45) minutes.The adhesions were also morbidly adherent to the vaginal wall where the mesh was palpable.The mesh was contracted largely at the vaginal vault and using sharp dissection, was mobilized from the vagina laterally and posteriorly.The mesh was sent to pathology for histology.The vaginotomy was closed with continuous #2-0 vicryl sutures.60mls of normal saline flooded the retropubic space.A 2cm sub-umbilical incision was made and the tape was placed suburethrally without tension.Cystoscopy confirmed both ureters to be functioning normally and the bladder mucosa to be intact.The trocar sites and the vaginal mucosa was closed with #3-0 vicryl rapide.Routine post operative orders including nil by mouth for four (4) hours with scds utilized overnight.Vaginal pack, iv & idc out at 0600hrs on saturday with a trial of void.Surgery was covered by antibiotics and clexane whilst an in-patient.Teds for fourteen days post operatively.

Manufacturer Narrative

Block b3 date of event: date of event was approximated to april 06, 2011, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.(b)(6) hospital.(b)(6).Block h6: patient code 2348 captures the reportable event of unspecified injury.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complaint device 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.Block h11: blocks a1, b3, e1, and g2 have been corrected.Blocks b2, b5, d6b, h6 and h10 have been updated based on the additional information received on december 8, 2022.Block b3 date of event: date of event was approximated to (b)(4) 2015, explant procedure date, as no event date was reported.Block e1: this complaint was received as litigation from a legal source in australia.This event was reported by the patient's legal representation.The implant surgeon is: (b)(6) md.(b)(6) hospital.(b)(6).The revision surgeon is: (b)(6).(b)(6) hospital.(b)(6).Tel #: (b)(6).Fax #: (b)(6).Block h6: patient code e1405 captures the reportable event of dyspareunia.Patient code e2101 captures the reportable event of adhesions.Patient code e2330 captures the reportable event of vaginal pain.Device code a0406 captures the reportable event of "contracted mesh." impact code f1903: device explantation was utilized to capture the event of laparoscopic excision of vaginal mesh.Impact code f12 has been used in the light of the patient sought legal recourse for a personal injury related to the device.

• 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: 11164856
• MDR Text Key: 226640216
• Report Number: 3005099803-2020-06748
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091131
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2011
• Device Model Number: M0068317010
• Device Catalogue Number: 831-701
• Device Lot Number: 1ML0083102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 65 YR
• Patient Sex: Female