MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PFR KIT UPHOLD LITE VAGINAL SUPPORT SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN

Model Number M0068317170

Device Problems Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Pain (1994); Scar Tissue (2060); Prolapse (2475); Dyspareunia (4505); Insufficient Information (4580)

Event Date 06/03/2020

Event Type  Injury  

Manufacturer Narrative

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 the mesh removal surgery.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.This event was reported by the patient's legal representation.The implant surgeon is: (b)(6).(b)(4).The removed 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

Note: this manufacturer report pertains to the second of three devices used during the same procedure.It was reported to boston scientific corporation that an uphold vaginal support system device, pinnacle pelvic floor repair kits, and an advantage fit system were implanted into the patient during a procedure performed on (b)(6) 2013.Reportedly, the patient had the implanted mesh devices removed on (b)(6) 2020.

Manufacturer Narrative

Correction - blocks b5 and h6: patient code (below) 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 the mesh removal surgery.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: patient code e2401 captures the reportable event of an unspecified injury.Impact code f19 captures the reportable event of surgical intervention.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the removed 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

Note: this manufacturer report pertains to the second of three devices used during the same procedure.It was reported to boston scientific corporation that an uphold vaginal support system device, pinnacle pelvic floor repair kits, and an advantage fit system were implanted into the patient during a procedure performed on (b)(6), 2013.After the procedure, the patient experienced an unspecified injury and ultimately had the implanted mesh devices removed on(b)(6), 2020.

Event Description

Note: this manufacturer report pertains to the first of three devices used during the same procedure.It was reported to boston scientific corporation that an uphold vaginal support system device, pinnacle pelvic floor repair kits, and an advantage fit system were implanted into the patient during a procedure performed on (b)(6) 2013.After the procedure, the patient experienced an unspecified injury and ultimately had the implanted mesh devices removed on (b)(6) 2020.The device was not returned for analysis.Additional information received as of 19oct2022: vaginal hysterectomy, vaginal anterior & posterior repair were the procedures performed on (b)(6) 2013, for treatment of uterovaginal prolapse and urinary incontinence.On (b)(6) 2020, the patient underwent removal of pinnacle and uphold mesh, bilateral paravaginal dissection, bilateral pararectal dissection, removal of advantage sling, urethral lysis, anterior colpoperineorrhaphy.The patient experienced vaginal pain, dyspareunia, vaginal scarring, vaginal prolapse, scarred rigid vaginal canal, exposed mesh and urethral scarring.The surgeon noted that the procedure was complicated due to severe scarring in the pelvic floor, anteriorly, posteriorly, and laterally, as well as under the urethra.The uphold mesh was folded and exposed at the upper anterior vaginal wall.Vaginal prolapse with cystocele and rectocele was evident.The patient tolerated the procedure well and was transferred to the recovery room excellent condition.

Manufacturer Narrative

Correction - blocks b5 and h6: patient code (below).Block b3: the exact event onset date is unknown.The provided event date of june 3, 2020 was chosen as a best estimate based on the date of the mesh removal surgery.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).The explanting surgeon is: dr.(b)(6).Block h6: patient code e1405, e1715, e2330, e2333 and e2006 captures the reportable event of dyspareunia, scar tissue, pain, prolapse and erosion impact code f1903 captures the reportable event of device explantation.Block h11: block b5 was updated block d4: upn, lot number, expiration date and implantation date were updated block g1 was updated block g2: report source was corrected block g4: premarket 510k was updated block h4: manufacturing date has been updated.

• Brand Name: PFR KIT UPHOLD LITE VAGINAL SUPPORT SYSTEM
• 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): LUMENIS; 2077 gateway place suite 300; san jose CA 95110
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 11588022
• MDR Text Key: 242905670
• Report Number: 3005099803-2021-01279
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K122459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/15/2022

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: 08/31/2015
• Device Model Number: M0068317170
• Device Catalogue Number: 831-717
• Device Lot Number: ML00000945
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/02/2021
• Initial Date FDA Received: 03/30/2021
• Supplement Dates Manufacturer Received: 04/20/2021; 10/19/2022
• Supplement Dates FDA Received: 05/17/2021; 11/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female