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 Problems Difficult or Delayed Positioning (1157); Material Twisted/Bent (2981)

Patient Problem Pain (1994)

Event Date 09/10/2018

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a pinnacle posterior pelvic floor repair kit was implanted during a bilateral sacrospinous ligament fixation using pinnacle technique, vaginal repair of enterocele and rectocele, and proctoplasty procedure performed on (b)(6) 2010.The patient, who previously had a hysterectomy, now presented with pelvic relaxation and a sensation of everything falling out of her posterior aspect of her vagina, although she had good anterior support.She was noted to have a posterior defect and finally elected to have a rectocele repaired.The patient knew that there could be a chance for damage to the bowel or bladder, hemorrhage, infection, time off work, graft erosion, or need for reoperation in the future.As reported by the patient's attorney, the patient had experienced an unspecified injury.On (b)(6) 2018, the patient underwent the removal of the posterior gynecological mesh.The patient had experienced vaginal pain and hip pain.Findings included an extremely tense, folded band of vaginal mesh under the apex of the vagina.The mesh was separated at midline and dissected from sacrospinous ligament to sacrospinous ligament with significant release of tension.Palpation revealed that more that 90-95% of the mesh was removed.Multiple rectovaginal exams during the procedure revealed no defect.

Manufacturer Narrative

Date of event was approximated to (b)(6) 2018, the date the sling was explanted, as no event date was reported.This event was reported by the patient's legal representative.The implanting surgeon is: dr.(b)(6).The revision surgeon is: dr.(b)(6).(b)(4).

• 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: 15543509
• MDR Text Key: 301187936
• Report Number: 3005099803-2022-05628
• 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: 10/05/2022

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: 01/31/2011
• Device Model Number: M0068317100
• Device Catalogue Number: 831-710
• Device Lot Number: 1ML0010607
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/08/2022
• Initial Date FDA Received: 10/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Race: White