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); Discomfort (2330); Prolapse (2475); Insufficient Information (4580)

Event Date 01/09/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2020 was chosen as a best estimate based on the date of revision surgery.The complainant was unable to provide the suspect device lot number; therefore, the device manufacture date and expiration date is unknown.This event was reported by the patient's legal representation.The implant surgery was performed by: dr.(b)(6).(b)(6) medical center.(b)(6).The revision surgery was performed by: dr.(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 the patient was diagnosed with cystocele, vaginal vault prolapse and urinary incontinence.On (b)(6) 2019, she was implanted with a pinnacle pelvic floor repair kit during an anterior repair with insertion of mesh to the sacrospinous ligaments, vaginal vault suspension with insertion of mesh to the sacrospinous ligaments, placement of a synthetic suburethral sling and cystourethroscopy procedure.She tolerated the procedure well.Bladder challenge was instituted per protocol and the patient failed to urinate an adequate volume.Foley was reinserted and the patient was instructed then she would go home with a leg bag.On (b)(6) 2020, the patient underwent suburethral sling removal and cystoscopy, rectocele repair with dermal graft implantation and vaginal colpopexy procedure due to vaginal mesh erosion, rectocele, atrophic vaginitis and vaginal prolapse.

Manufacturer Narrative

Correction - d4: model number, d4: unique identifier (udi) #, and h6: patient codes patient code e2401 for atrophic vaginitis was removed as it is unrelated to the mesh or implant procedure.Block b3: the exact event onset date is unknown.The provided event date of (b)(6) 2020 was chosen as a best estimate based on the date of revision surgery.Block e1: this event was reported by the patient's legal representation.The implant surgery was performed by: dr.(b)(6).(b)(6) medical center.(b)(6).The revision surgery was performed by: dr.(b)(6).Block h6: patient codes e2006, e2311 and impact code f19 capture the reportable events of vaginal mesh erosion, discomfort and additional surgery.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: 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 the patient was diagnosed with cystocele, vaginal vault prolapse and urinary incontinence.On (b)(6) 2009, she was implanted with a pinnacle pelvic floor repair kit during an anterior repair with insertion of mesh to the sacrospinous ligaments, vaginal vault suspension with insertion of mesh to the sacrospinous ligaments, placement of a synthetic suburethral sling and cystourethroscopy procedure.She tolerated the procedure well.Bladder challenge was instituted per protocol and the patient failed to urinate an adequate volume.Foley was reinserted and the patient was instructed then she would go home with a leg bag.On (b)(6) 2020, the patient underwent suburethral sling removal and cystoscopy, rectocele repair with dermal graft implantation and vaginal colpopexy procedure due to vaginal mesh erosion, rectocele, atrophic vaginitis and vaginal prolapse.

• 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
• MDR Report Key: 11419084
• MDR Text Key: 239428623
• Report Number: 3005099803-2021-00869
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: K071957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 04/15/2021

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 Model Number: M0068317050
• Device Catalogue Number: 831-705
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/09/2021
• Initial Date FDA Received: 03/05/2021
• Supplement Dates Manufacturer Received: 03/19/2021
• Supplement Dates FDA Received: 04/15/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR