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

Model Number M0068317080

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

Patient Problems Incontinence (1928); Pain (1994); Dyspareunia (4505); Insufficient Information (4580)

Event Date 06/19/2020

Event Type  Injury  

Manufacturer Narrative

Patient identifier: (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 upsylon y-mesh was implanted into the patient on (b)(6) 2011.The patient experienced complications and nonsurgical treatment.Patient symptoms include: vaginal pain; pelvic pain; groin pain; thigh pain; painful intercourse; recurrent incontinence; damage.Nonsurgical treatments: on (b)(6) 2020 the patient commenced pain medication: amitriptyline for the treatment of: pain in pelvic floor.Treatment duration: 4 months.On (b)(6) 2020 the patient commenced physiotherapy treatment: pelvic floor exercises to relieve pain.Treatment duration: 4 months.On (b)(6) 2020 the patient commenced topical treatment (including oestrogen cream): topical endep cream for the treatment of: pain relief.Treatment duration: 11 months.On (b)(6) 2021 the patient commenced injections (not associated with surgical treatment): steroid for the treatment of: pain relief for groin.Treatment duration: 1 injection.

Event Description

It was reported to boston scientific corporation that an upsylon y-mesh was implanted into the patient on october 18, 2011.The patient experienced complications and nonsurgical treatment.Patient symptoms include: vaginal pain; pelvic pain; groin pain; thigh pain; painful intercourse; recurrent incontinence; damage nonsurgical treatments: on (b)(6) 2020 the patient commenced pain medication: amitriptyline for the treatment of: pain in pelvic floor.Treatment duration: 4 months.On (b)(6) 2020 the patient commenced physiotherapy treatment: pelvic floor exercises to relieve pain.Treatment duration: 4 months.On (b)(6) 2020 the patient commenced topical treatment (including oestrogen cream): topical endep cream for the treatment of: pain relief.Treatment duration: 11 months.On (b)(6) 2021 the patient commenced injections (not associated with surgical treatment): steroid for the treatment of: pain relief for groin.Treatment duration: 1 injection.Boston scientific received an additional information on august 11, 2022 as follows: it was reported to boston scientific corporation that an uphold vaginal support system device was implanted into the patient during a sacrospinous colpopexy procedure performed on (b)(6) 2011 for the treatment of rectocele and enterocele.The patient experienced the following complications after the procedure: vaginal pain, pelvic pain, groin pain, thigh pain, painful intercourse, recurrent incontinence, damage.The patient was then required nonsurgical treatments to relieve the symptoms: on (b)(6) 2020 the patient commenced pain medication: amitriptyline for the treatment of: pain in pelvic floor.Treatment duration: 4 months.On (b)(6) 2020 the patient commenced physiotherapy treatment: pelvic floor exercises to relieve pain.Treatment duration: 4 months.On (b)(6) 2020 the patient commenced topical treatment (including oestrogen cream): topical endep cream for the treatment of: pain relief.Treatment duration: 11 months.On (b)(6) 2021 the patient commenced injections (not associated with surgical treatment): steroid for the treatment of: pain relief for groin.Treatment duration: 1 injection.

Manufacturer Narrative

Block h2: additional information.Block a1: patient identifier (b)(6) added.Block b5 narrative updated.Block d4 model number, lot number and expiration date updated.Block g1 manufacturing site updated.Block h4 manufacturing date updated.Block b3 date of event: date of event was approximated to (b)(6) 2011, implant procedure date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Block h6: patient code e1405, e2330 capture the reportable events of dyspareunia and pain impact code f12 and f2303 has been used in the light of this patient had filed a legal claim for the injuries related to the device and the prescribed medications.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device is not available for return; therefore, a device analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• Brand Name: UPHOLD 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): 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: 13052760
• MDR Text Key: 282564277
• Report Number: 3005099803-2021-06782
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K081048
• 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
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2011
• Device Model Number: M0068317080
• Device Catalogue Number: 831-708
• Device Lot Number: 1ML0070603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2010
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 92 KG