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

Model Number M0068317100

Device Problems Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Erosion (1750); Discomfort (2330); No Code Available (3191)

Event Date 02/19/2013

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2013, 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 pelvic floor repair kits device was implanted into the patient during posterior pinnacle + suspension and repair of enterocele procedure performed on (b)(6) 2013.As reported by the patient's attorney, after the implantation, the patient experienced discomfort.It was not painful rather the sensation of a lump when sitting and lying.On examination, there was a posterior wall erosion and tenderness on the left posterior arm.Subsequently, the patient had revision surgery on (b)(6) 2018 for eua, cystoscopy, cystodistention, pr and rectal examination which found 0.5 x 1cm mesh exposure approx.3cm proximal to posterior fourchette.Boston scientific has been unable to obtain additional information regarding the event to date.

Manufacturer Narrative

Blocks b5 and h6 patient codes and impact codes have been updated based on the additional information received on december 14, 2022.Block b3 date of event: date of event was approximated to february 19, 2013, implant date, as no event date was reported.Block e1: this complaint was received as litigation from a legal source in australia.The implant surgeon is: dr.(b)(6).(b)(6) hospital.Revision surgery surgeons: dr.(b)(6).Dr.(b)(6).(b)(6) hospital.Block h6: imdrf patient codes e2006, e2101 and e2311 capture the reportable events of erosion and revision surgery.Imdrf impact codes f1905 capture the reportable event of extensive mesh excision surgery.Block h11: block g2 report source has been corrected.

Event Description

It was reported to boston scientific corporation that a pinnacle pelvic floor repair kits device was implanted into the patient during posterior pinnacle cervical suspension + repair of enterocele procedure performed on (b)(6), 2013 for the treatment of enterocele and vault descent.As reported by the patient's attorney, after the implantation, the patient experienced discomfort.It was not painful rather the sensation of a lump when sitting and lying.On examination, there was a posterior wall erosion and tenderness on the left posterior arm.Subsequently, the patient had revision surgery on november 2, 2018 for eua, cystoscopy, cystodistention, pr and rectal examination which found 0.5 x 1cm mesh exposure approx.3cm proximal to posterior fourchette.On (b)(6), 2019, the patient underwent revision surgery of excision of vaginal mesh including bilateral groin dissection, and diagnostic laparoscopy and division of adhesions.However, in view of extensive dissection and prolonged anesthetic, hysterectomy and repairs procedures could not be done.Findings showed deep pod, postoperative delirium redundant sigmoid, sigmoid colon loop adherent to anterior pelvic peritoneum where mesh can be appreciated - no fistulation into this sigmoid loop.No rectal involvement.During the procedure, mesh arm was densely adhered to periosteum and was dissected off from the bladder.Body of mesh divided centrally.At this point, it was evident that the body of the mesh was "pulled over" towards the right vaginal wall with part of the body pulled into the arm tracts.Dissection of posterior compartment until mesh encountered 3cm proximal to introitus.Mesh dissected off the recto-vaginal septum.Remainder of the body of mesh dissected laterally.Right arm dissected to the level of sacrospinous ligament, short arm due to displaced body.Unable to dislodge mesh arm from right sacrospinous ligament, therefore arm divided at the level of sacrospinous ligament.

• 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: 11175538
• MDR Text Key: 227052775
• Report Number: 3005099803-2021-00112
• 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: Other,Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/04/2023

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
• Device Expiration Date: 08/31/2014
• Device Model Number: M0068317100
• Device Catalogue Number: 831-710
• Device Lot Number: ML00000247
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 01/14/2021
• Supplement Dates Manufacturer Received: 12/14/2022
• Supplement Dates FDA Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2011
• 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