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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Hemorrhage/Bleeding (1888); Pain (1994); Discomfort (2330); Prolapse (2475); Dysuria (2684); Constipation (3274); Dyspareunia (4505); Urinary Incontinence (4572)

Event Date 01/19/2016

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a pinnacle pelvic floor repair kits device was implanted into the patient during a posterior vaginal repair with pinnacle mesh procedure performed on (b)(6) 2016 for the treatment of recurrent recto-enterocele post vaginal hysterectomy and conventional posterior repair.According to reports, the patient has had intermittent bladder difficulties and sore genitals since the implantation.The patient arrived to the clinic on (b)(6) 2016, with an apparent cystocele.On (b)(6) 2016, the patient presented with complaints of vaginal pain, fatigue, and numerous joint aches.The patient returned to the clinic for a check-up on (b)(6) 2017.According to reports, the patient had vaginal mesh removed in (b)(6) 2016.The patient is quite upset because this is impacting her quality of life.She experiences pain in her back and buttocks while walking and lying down.Furthermore, because of dyspareunia and post-coital bleeding, this affects with her connection with her husband.She also had pain while urinating, and she is now obliged to digitate to open her intestines.The vagina was well estrogenized throughout the examination.It was quite tender, especially on the right vaginal wall, where a tender tight band could be felt, and at the vault, where a tight band could also be felt.There was additional tenderness on the right vaginal wall.Furthermore, the patient was thoroughly discussed management choices.In order to alleviate her problems, the patient chose to have an anesthetic examination, cystoscopy, vault band division, and removal of the right sided band of mesh or adhesions.

Manufacturer Narrative

Date of event was approximated to (b)(6) 2016, implant procedure date, as no event date was reported.The patient underwent a mesh excision on (b)(6) 2016.(b)(6).(b)(4).The complainant indicated that the device is not available for return; therefore, a device 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 posterior pelvic floor repair kit device was implanted into the patient during a posterior vaginal repair with pinnacle mesh procedure performed on (b)(6) 2016 for the treatment of recurrent recto-enterocele post vaginal hysterectomy and conventional posterior repair.According to reports, the patient has had intermittent bladder difficulties and sore genitals since the implantation.The patient arrived to the clinic on (b)(6) 2016, with an apparent cystocele.The posterior wall was fairly well-supported with some undissolved suture noted; upon standing she had an obvious cystocele.On (b)(6) 2016, the patient presented with complaints of vaginal pain, fatigue, and numerous joint aches.The patient returned to the clinic for a check-up on (b)(6), 2017.According to reports, the patient had vaginal mesh removed in (b)(6) 2016.The patient is quite upset because this is impacting her quality of life.She experiences pain in her back and buttocks while walking and lying down.Furthermore, because of dyspareunia and post-coital bleeding, this affects with her connection with her husband.She also had pain while urinating, and she is now obliged to digitate to open her bowels.The vagina was well estrogenized upon examination.It was quite tender, especially on the right vaginal wall, where a tender tight band could be felt, and at the vault, where a tight band could also be felt.There was additional tenderness on the right vaginal wall.Furthermore, the patient was thoroughly discussed management choices.In order to alleviate her problems, the patient chose to have an anesthetic examination, cystoscopy, vault band division, and removal of the right sided band of mesh or adhesions.

Manufacturer Narrative

Block h2: correction blocks b5, b7 and h6 (patient code) has been corrected.Block b3 date of event: date of event was approximated to (b)(6) 2016, implant procedure date, as no event date was reported.Block d6b explant date: the patient underwent a mesh excision on (b)(6) 2016.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.Ron jewell south west gynaecology locked bag no.12, bunbury wa 6231 united states block h6: patient code e1405, e1301, e2101, e2330, capture the reportable events of dyspareunia, dysuria, adhesions and pain.Impact code f1905 has been used to capture the reportable event of mesh excision.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device is not available for return; therefore, a device analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• 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: 15333735
• MDR Text Key: 299043643
• Report Number: 3005099803-2022-04956
• 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: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: M0068317100
• Device Catalogue Number: 831-710
• Device Lot Number: ML00002045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female