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 Problem Positioning Problem (3009)

Patient Problems Adhesion(s) (1695); Erosion (1750); Micturition Urgency (1871); Pain (1994); Prolapse (2475)

Event Date 05/08/2013

Event Type  Injury  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2013, the date the sling was implanted, as no event date was reported.Initial reporter name and address: this event was reported by the patient's legal representative.The implant surgeon is: dr.(b)(6).(b)(4).

Event Description

Note: this manufacturer report pertains to one of two devices used on the same patient.It was reported to boston scientific corporation that a pinnacle pelvic floor repair kits and an advantage fit system were implanted during a posterior colporrhaphy augmented with mesh (posterior pinnacle), tension-free sub-urethral sling (advantage fit), sacrospinous ligament vaginal vault suspension, and cystourethroscopy procedure performed on (b)(6) 2013, for the treatment of recurrent rectocele, perineocele, stress urinary incontinence, urethral hypermobility, and dysfunctional voiding.It was noted that the patient had a posterior repair done a few years ago and since that time has had difficulty defecating properly and a return of the pelvic prolapse symptoms.She also continued to be incontinent of urine with stress maneuvers.At the time of her last surgery, she had some periurethral type bulking done.A sling was not done at that time because of her dysfunctional valsalva voiding.The physician and the patient discussed the different surgical options for her, and they felt that because the rectocele had returned in a relatively short time, perhaps it was warranted to use a mesh posteriorly.The patient was advised that she may have a higher complication rate because of her diabetes.During the procedure, cystoscopy was performed after placement of the advantage fit.It was noted that the right sling arm had entered the bladder.It was removed and replaced without difficulty.On (b)(6) 2018, the patient underwent excision of vaginal mesh, revision of posterior colporrhaphy, and cystourethroscopy.The patient had vaginal mesh erosion, urinary urgency, and rectocele.She has recently been having more pain on the right-hand side.She wanted to be evaluated to see if perhaps the previously placed mesh had caused some of the pain.Upon evaluation, it was found that a 1 x 2 cm mesh erosion in the mid vaginal in the posterior compartment.The physician and the patient discussed the different options and felt that excising the mesh would be the best option.She was appropriately consented on an outpatient basis and arrived at the hospital for the procedure.During the exam under anesthesia, it revealed the previously seen 1 x 2 cm vaginal mesh erosion in the mid-posterior vaginal compartment.Careful evaluation under anesthesia also revealed some bands and some tightness in the right sacrospinous ligament mesh arm.A circumferential incision was then made overlying the mesh erosion.The specimen was removed.The edges were then undermined.At this point, it was apparent that there was a recurrent rectocele.We then dissected back towards the apex further.The tight sacrospinous ligament mesh arm was then truncated, loosening the arm and removing the tension.The recurrent rectocele was then repaired with a 2-0 pds suture.Copious irrigation was then used.The midline incision was then closed using 2-0 vicryl.The foley catheter was then removed.A 70-degree cystoscope was placed in the bladder.There was no damage to the bladder, no gross stones, polyps, or other abnormalities.Vigorous bilateral ureteral jets were visualized.The urethra was inspected and was free of any damage or foreign bodies.The rectal exam was then performed.There was no damage to the rectum, and there was no decreased rectal caliber.The patient was then awakened from the anesthesia and taken to the recovery room in stable condition.During the exam under anesthesia, it revealed the previously seen 1 x 2 cm vaginal mesh erosion in the mid-posterior vaginal compartment.Careful evaluation under anesthesia also revealed some bands and some tightness in the right sacrospinous ligament mesh arm.A circumferential incision was then made overlying the mesh erosion.The specimen was removed.The edges were then undermined.At this point, it was apparent that there was a recurrent rectocele.We then dissected back towards the apex further.The tight sacrospinous ligament mesh arm was then truncated, loosening the arm and removing the tension.The recurrent rectocele was then repaired with a 2-0 pds suture.Copious irrigation was then used.The midline incision was then closed using 2-0 vicryl.The foley catheter was then removed.A 70-degree cystoscope was placed in the bladder.There was no damage to the bladder, no gross stones, polyps, or other abnormalities.Vigorous bilateral ureteral jets were visualized.The urethra was inspected and was free of any damage or foreign bodies.The rectal exam was then performed.There was no damage to the rectum, and there was no decreased rectal caliber.The patient was then awakened from the anesthesia and taken to the recovery room in stable condition.

• 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: 15461545
• MDR Text Key: 300305294
• Report Number: 3005099803-2022-05373
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2015
• Device Model Number: M0068317100
• Device Catalogue Number: 831-710
• Device Lot Number: ML00000993
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female