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

Model Number M0068318170

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Incontinence (1928); Laceration(s) (1946); Pain (1994); Perforation (2001); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505)

Event Date 03/03/2021

Event Type  Injury  

Manufacturer Narrative

(b)(6) the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.The upn provided was chosen as a representative upn to capture the implanted device.The complainant indicated that the device is not available for return; 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 an uphold lite was implanted on (b)(6) 2014.The patient experienced complications and nonsurgical treatment.Patient symptoms include: back pain; vaginal pain; pelvic pain; anal pain; thi pain; pain inter; inab inter; rec incont; psych.Nonsurgical treatments: the patient was treated with psychological medication: poraxtine for the treatment of: anxiety.Treatment duration: 6.On (b)(6) 2021 the patient commenced topical treatment (including oestrogen cream): estriol for the treatment of: in continence.Treatment duration: ongoing.

Event Description

It was reported to boston scientific corporation that an uphold lite was implanted on january 31, 2014.The patient experienced complications and nonsurgical treatment.Patient symptoms include: back pain; vaginal pain; pelvic pain; anal pain; thi pain; pain inter; inab inter; rec incont; psych.Nonsurgical treatments: the patient was treated with psychological medication: poraxtine for the treatment of: anxiety.Treatment duration: 6.On (b)(6) 2021 the patient commenced topical treatment (including oestrogen cream): estriol for the treatment of: in continence.Treatment duration: ongoing.Additional information received on august 24, 2022.The procedures performed on (b)(6) 2014 were uphold lite mesh implant, anterior and posterior repair, cystoscopy, bilateral labiaplasty, repair of bladder injury, and retrograde ureterogram to treat the patient's post hysterectomy prolapse, vault descent to +1 cm, cystocele to +1 cm, rectocele to +2 cm, accidental bladder injury left side of trigone near left ureteric orifice, pathologically enlarged labia minora with left sided tear, and small circular "hole" right.In the physician's assessment, the patient will need an indwelling catheter for 10 days and then have cystogram.Removal of catheter post trial of voiding.

Manufacturer Narrative

Block a1: meshc-20210923-f8a81020.Block h10: the complainant indicated that the device is not available for return; 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.Block h11: blocks a1, b5, d4, d6a, g1, and h10 have been updated based on the additional information received on august 24, 2022.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Block h6: patient code e1405 captures the reportable event of dyspareunia.Patient code e2330 captures the reportable event of pain.Impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.

Event Description

It was reported to boston scientific corporation that an uphold lite was implanted on (b)(6) 2014.The patient experienced complications and nonsurgical treatment.Patient symptoms include: back pain; vaginal pain; pelvic pain; anal pain; thi pain; pain inter; inab inter; rec incont; psych nonsurgical treatments: the patient was treated with psychological medication: poraxtine for the treatment of: anxiety.Treatment duration: 6.On march 3, 2021 the patient commenced topical treatment (including oestrogen cream): estriol for the treatment of: in continence.Treatment duration: ongoing.***additional information received on august 24, 2022*** the procedures performed on (b)(6) 2014 were uphold lite mesh implant, anterior and posterior repair, cystoscopy, bilateral labiaplasty, repair of bladder injury, and retrograde ureterogram to treat the patient's post hysterectomy prolapse, vault descent to +1 cm, cystocele to +1 cm, rectocele to +2 cm, accidental bladder injury left side of trigone near left ureteric orifice, pathologically enlarged labia minora with left sided tear, and small circular "hole" right.In the physician's assessment, the patient will need an indwelling catheter for 10 days and then have cystogram.Removal of catheter post trial of voiding.

Manufacturer Narrative

Block a1: meshc-20210923-f8a81020 block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr (b)(6) (b)(6) hospital australia block h10: the complainant indicated that the device is not available for return; 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.Block h11: blocks h6 and h10 have been updated based on the correction from medical safety received on september 16, 2022.Block h6: patient code e2330 captures the reportable event of pain.Patient code e2114 captures the reportable events of labia hole and the bladder injury (perforation).Patient code e1405 captures the reportable event of dyspareunia.Patient code e0206 captures the reportable event of unspecified mental, emotional or behavioural problem.Patient code e2009 captures the reportable event of labia tear (laceration).Impact code f1901 captures the reportable event of bladder injury repair (additional surgery).Impact code f23 captures the reportable event of indwelling catheter (unexpected medical intervention).Impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.

• Brand Name: UPHOLD LITE
• 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: 12928661
• MDR Text Key: 286345789
• Report Number: 3005099803-2021-06775
• Device Sequence Number: 1
• Product Code: OTP
• UDI-Device Identifier: 08714729839200
• UDI-Public: 08714729839200
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: ML00001983
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/30/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 70 KG