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 Prolapse (2475); No Code Available (3191); Constipation (3274)

Event Date 08/06/2013

Event Type  Injury  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2013, implant date, as no event date was reported.This event was reported by the patient's legal representation.The mesh was implanted by: (b)(6).(b)(4).The removed segment of mesh 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 a pinnacle pelvic floor repair kits was implanted into the patient during a posterior vaginal repair w/ mesh and bilateral sacrospinous fixation procedure performed (b)(6) 2013 to treat rectocele and enterocele.As reported by the patient's attorney, on (b)(6) 2013, the patient underwent a revision surgery for constipation since the implantation.Proctoscopy suggested that the mesh arm on the left side was too tight causing problems with peristalsis and emptying of the descending colon into the rectum.The segment of left mesh arm was then removed.On (b)(6) 2014, the patient underwent another surgery for division of mesh arms posterior and insertion of a non-bsc tfs tape due to enterocele/cystocele.

Manufacturer Narrative

Correction to block e1 healthcare facility phone number.Please see updated content below.B3 date of event: date of event was approximated to august 6, 2013, implant date, as no event date was reported.E1: this event was reported by the patient's legal representation.The mesh was implanted by: (b)(6).H6: patient code e1007 captures the reportable event of constipation requiring revision surgery.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.H10: the removed segment of mesh 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 a pinnacle pelvic floor repair kits was implanted into the patient during a posterior vaginal repair w/ mesh and bilateral sacrospinous fixation procedure performed (b)(6) 2013 to treat rectocele and enterocele.As reported by the patient's attorney, on (b)(6) 2013, the patient underwent a revision surgery for constipation since the implantation.Proctoscopy suggested that the mesh arm on the left side was too tight causing problems with peristalsis and emptying of the descending colon into the rectum.The segment of left mesh arm was then removed.On (b)(6) 2014, the patient underwent another surgery for division of mesh arms posterior and insertion of a non-bsc tfs tape due to enterocele/cystocele.

• 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: 11130721
• MDR Text Key: 225493491
• Report Number: 3005099803-2020-06558
• 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: 03/01/2021

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 Expiration Date: 06/30/2015
• Device Model Number: M0068317100
• Device Catalogue Number: 831-710
• Device Lot Number: ML00000789
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/11/2020
• Initial Date FDA Received: 01/07/2021
• Supplement Dates Manufacturer Received: 02/08/2021
• Supplement Dates FDA Received: 03/01/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR