MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPSYLON Y MESH KIT; GYNECOLOGIC LAPAROSCOPE AND ACCESSORIES

Model Number M0068318220

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

Patient Problems Erosion (1750); Incontinence (1928); Pain (1994); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Insufficient Information (4580)

Event Date 11/21/2018

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 upsylon y-mesh was implanted on (b)(6) 2018.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh), vaginal pain, pelvic pain, groin pain, anal pain, rectal pain, painful intercourse, inability to have intercourse,difficulties with bowel motions,incontinence not present before implant, damage, and psychiatric injury.Surgical interventions: on (b)(6) 2019 the patient underwent further surgery regarding the upsylon y-mesh implant for the following purpose: repair mesh that had come away after first surgery.Nonsurgical treatments: on (b)(6) 2018 the patient commenced pain medication: panadol; helps with the dull throbbing pain in groin and lower stomach area (right side).Treatment duration: 3 years.On (b)(6) 2018 the patient commenced physiotherapy treatment (including pelvic floor exercises or training).

Manufacturer Narrative

Block h2: additional information block a1, b5, d4, h4, h6 have been updated based on additional information received on august 19, 2022.Block a1: meshc-20210930-88250c13.Block b3 date of event: the exact event onset date is unknown.The provided event date of november 21, 2018 was chosen as a best estimate based on the date of the mesh was implanted.Block e1: this event was reported by the patient's legal representation.The implanting surgeon is: dr.(b)(6).Block h6: patient code e1405, e2401, e2006, e0206, e2330 capture the reportable events of dyspareunia, unspecified personal injury, erosion, unspecified mental, emotional or behavioural problem impact code f1901, f12, f2303 capture the reportable events of additional surgery, patient had filed for a claim due to unspecified personal injury and medication required.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.The complaint device is not expected to be returned for evaluation; therefore, a device analysis of the complaint device could not be completed.If any further relevant information is received, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that an upsylon y mesh kit device was implanted into the patient during a laparoscopic sacral colpopexy procedure performed on (b)(6), 2018, for the treatment of recurrent vaginal prolapse, including vaginal vault prolapse.After the procedure, the patient experienced complications that required nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh), vaginal pain, pelvic pain, groin pain, anal pain, rectal pain, painful intercourse, inability to have intercourse, difficulties with bowel motions, incontinence, damage, and psychiatric injury.On (b)(6), 2018, the patient commenced treatment with panadol for groin and stomach pain.The patient also underwent physiotherapy.Treatment with this medication and therapy is ongoing.According to reports, the patient experienced a recurring rectocele and underwent a posterior vaginal repair on (b)(6), 2019.A hydrodissection was performed during the surgery to help with the posterior vaginal wall dissection.A full thickness incision was created in the posterior vaginal wall.The recto-vaginal plane was entered, and the dissection advanced all the way to the vaginal apex and each pelvic side wall.A colporrhaphy method was used to restore prerectal tissue in the higher posterior vagina.The rectovaginal septum was mobilized and reattached to the levator muscles on each side of the prerectal tissue in the mid vagina.Moreover, saline solution was liberally applied to the wound.The posterior vaginal wall was then closed with excellent hemostasis.The examination revealed that she had great vaginal capacity.Furthermore, at the conclusion of the operation, a rectal examination was performed, and no rectal injury or damage was found.A properly sized surgical-pelvic organ pessary (s-pop) device was sutured into place in the vaginal canal.A urethral catheter and a vaginal pack were placed.Prophylactic antibiotics and fragmin were administered before the procedure.

• Brand Name: UPSYLON Y MESH KIT
• Type of Device: GYNECOLOGIC LAPAROSCOPE AND ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): PROXY BIOMEDICAL LIMITED; coilleach spiddal; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12929118
• MDR Text Key: 286847895
• Report Number: 3005099803-2021-06697
• Device Sequence Number: 1
• Product Code: OHD
• UDI-Device Identifier: 08714729848103
• UDI-Public: 08714729848103
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 09/15/2022

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: 05/31/2021
• Device Model Number: M0068318220
• Device Catalogue Number: 72912
• Device Lot Number: C003737
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2018
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 65 KG