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); Incontinence (1928); Pain (1994); Abnormal Vaginal Discharge (2123); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505)

Event Date 06/14/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.The upn provided was chosen as a representative upn to capture the implanted device.The complainant indicated that the device is not available for return; 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 an uphold was implanted on (b)(6) 2014 and a solyx was implanted on (b)(6) 2017.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); vaginal pain; other pain: lower abdominal pain; painful intercourse; offensive vaginal discharge; difficulties with bowel motions; recurrent incontinence; aggravated incontinence; psychiatric injury surgical interventions: on (b)(6) 2017 the patient underwent further surgery regarding the uphold implant under general anesthesia for the following purpose: excision.Nonsurgical treatments: on (b)(6) 2008 the patient commenced pain medication: panadol and nurofen for the treatment of: pain.Treatment duration: ongoing.On (b)(6) 2008 the patient commenced physiotherapy treatment (including pelvic floor exercises or training) for the treatment of: incontinence.On (b)(6) 2017 the patient commenced topical treatment (including oestrogen cream): cream (eleuthrat and vagifem) and pessaries (two lots).Treatment duration: 4 years straight and previously sporadically.Device 1 of 2.

Manufacturer Narrative

Blocks a1, b5 and section d: suspect medical device have been updated based on the additional information received on (b)(6) 2022.Block b3 date of event: date of event was approximated to (b)(6) 2017, based on the date the patient underwent surgical intervention.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Block h6: imdrf patient codes e2006, e2330, e1405 and e1401 capture the reportable events of erosion, pain, dyspareunia and abnormal vaginal discharge.Imdrf impact codes f19 capture the reportable event of surgical intervention.

Event Description

It was reported to boston scientific corporation that a pinnacle pelvic floor repair kits device was implanted into the patient during a lap assist vaginal hysterectomy + salpingectomy + anterior and posterior repair transvaginal sacrospinous fixation using pinnacle mesh + vulvar biopsy performed on (b)(6) 2014.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); vaginal pain; other pain: lower abdominal pain; painful intercourse; offensive vaginal discharge; difficulties with bowel motions; recurrent incontinence; aggravated incontinence; psychiatric injury surgical interventions: on (b)(6) 2017, the patient underwent further surgery regarding the pinnacle mesh implant under general anesthesia for the following purpose: excision.Nonsurgical treatments: on (b)(6) 2008, the patient commenced pain medication: panadol and nurofen for the treatment of: pain.Treatment duration: ongoing.On (b)(6) 2008, the patient commenced physiotherapy treatment (including pelvic floor exercises or training) for the treatment of: incontinence.On (b)(6) 2017, the patient commenced topical treatment (including oestrogen cream): cream (eleuthrat and vagifem) and pessaries (two lots).Treatment duration: 4 years straight and previously sporadically.

• 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): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12930746
• MDR Text Key: 286871081
• Report Number: 3005099803-2021-07390
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K071957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M0068317050
• Device Catalogue Number: 831-705
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 85 KG