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); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Obstruction/Occlusion (2422); Prolapse (2475); Hematuria (2558); Constipation (3274); Urinary Incontinence (4572)

Event Date 12/08/2009

Event Type  Injury  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2009, implant procedure date, as no event date was reported.This event was reported by the patient's legal representation.The implanting surgeon is: dr.(b)(6).(b)(6) medical center.(b)(6) united states.The explanting surgeon is: dr.(b)(6).(b)(6) united states.Adverse event problem: the following imdrf patient codes capture the reportable events of: e2006 - exposed vaginal mesh; e1304 - urinary urgency; e1401 - abnormal vaginal discharge; e2328 - no flow from left ureter; e0506 - blood loss of 1000 cc.The following imdrf impact codes capture the reportable events of: f1903 - removal of vaginal mesh; f2302 - blood transfusion; f2202 - placement of the glide wire during the procedure; f2303 - medication required.

Event Description

It was reported to boston scientific corporation that a pinnacle pelvic floor repair kit device was implanted into the patient during a transvaginal hysterectomy with bilateral salpingo - oophorectomy, anterior hammock using the pinnacle system with sacrospinous ligament fixation, posterior hammock using non - bsc mesh, and cystoscopy procedures on (b)(6) 2009, for the treatment of stage 4 complete uterine prolapse.Moreover, findings during the surgery were as follows: there was complete eversion of the vagina beyond the hymen level, both anteriorly and posteriorly; there was no posterior or anterior support.The uterus was approximately 6 - 7 weeks old with normal - looking tubes and ovaries.There was bilateral efflux of indigo carmine from both ureters immediately after the hysterectomy.After the anterior repair, the cystocele was reduced to an ap of 0, and the posterior vaginal wall gained a support of approximately 6 - 7 cm.There was a persistent paravaginal defect bilaterally.Re - examination with cystoscopy revealed efflux of indigo carmine from both ureters.There was noted as delayed efflux on the left ureter.A glide wire was introduced in the left ureter, which confirmed patency.There was eventual efflux of indigo carmine from this left ureter.Complications were noted as blood loss of 1000 cc requiring blood transfusion of 4 units packed rbcs intraoperatively.The patient tolerated the procedure well, and she was taken to the recovery room in stable condition.However, the patient claimed to have an extruded vaginal mesh after the operation.To address the problem, she had mesh removal surgery on (b)(6) 2013.A pelvic examination was conducted during the procedure, which found extruded vaginal mesh near the apex of the vagina.It was possible to isolate it using a clamp.The margins were resected 5 mm within the skin edge.The wound was treated copiously with saline.The remaining mesh was removed, followed by healthy tissue.Additionally, the patient tolerated the surgery well and was successfully extubated and moved to the recovery area in stable condition.On (b)(6) 2016, the patient went for a consultation with a chief complaint of prolapse, blood in the urine, a 6-month pessary recheck, and renal ultrasound.Reportedly, the patient has gross hematuria, which began several years ago.Cystoscopy showed exposed vaginal mesh.The cytology was negative.No treatment was provided for the hematuria.The patient had been seen by her primary care physician at which point microhematuria was noted, but since then there had been no further hematuria or vaginal bleeding.Moreover, the patient was seen on the last visit with a prolapse that has been present for approximately a year.Since the last visit, she has had better urinary symptoms.She has not had a bladder infection since the last visit.There is no abdominal pain.There is no back pain.She has constipation.No dysuria is noted.Patient has been emptying well.She has a frequency every 30 minutes.She has no nocturia.There is no odor with urination.There is a normal urinary stream.Patient states there is occasional stress incontinence and urgency.Most of the time, the patient has urgent incontinence.No further bleeding or cramping.Used estrace cream as directed, no dysuria or foul odor.Patient noted brownish discharge at time.No other vaginal complaints exist.Patient is also prescribed detrol la and ditropan xl for urinary symptoms.

• 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: 16709813
• MDR Text Key: 312985686
• Report Number: 3005099803-2023-01800
• 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: 04/10/2023

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: 03/31/2010
• Device Model Number: M0068317050
• Device Catalogue Number: 831-705
• Device Lot Number: 0ML9030302
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/17/2023
• Initial Date FDA Received: 04/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2009
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female