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

Model Number 72912

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

Patient Problems Erosion (1750); Incontinence (1928); Pain (1994); Abnormal Vaginal Discharge (2123); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Insufficient Information (4580)

Event Date 04/20/2017

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) 2017 and an obtryx was implanted on an unspecified date.The patient experienced complications and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); back pain; vaginal pain; pelvic pain; groin pain; thigh pain; inability to have intercourse; offensive vaginal discharge; difficulties with bowel motions; recurrent incontinence; aggravated incontinence; damage; psychiatric injury.Nonsurgical treatments: on (b)(6) 2017 the patient commenced pain medication: lyrica for the treatment of: pain.The patient was treated with incontinence medication: palexia for the treatment of: pain.Treatment duration: last year or so.On (b)(6) 2020 the patient commenced psychological medication: ditropan for the treatment of: to stop incontinence.Treatment duration: about 2 years.The patient was treated with physiotherapy treatment (including pelvic floor exercises or training).Device 1 of 2.

Manufacturer Narrative

Correction: d4: model number (it was only reported upsylon y-mesh device and no upn was provided).Block b3 date of event: date of event was approximated to april 20, 2017, implant date, as no event date was reported.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 surgeons are: dr.(b)(6) block h6: patient codes e2006, e2330, e1405 and e2324 capture the reportable events of erosion, pain, dyspareunia and incontinence that required medical intervention.Impact code f12 has been used in the light of the patient sought legal recourse for an unspecified personal injury related to the device.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complaint device is not expected to be returned for evaluation; therefore, a problem 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) 2017 and an obtryx was implanted on an unspecified date.The patient experienced complications and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); back pain; vaginal pain; pelvic pain; groin pain; thigh pain; inability to have intercourse; offensive vaginal discharge; difficulties with bowel motions; recurrent incontinence; aggravated incontinence; damage; psychiatric injury nonsurgical treatments: on (b)(6), 2017 the patient commenced pain medication: lyrica for the treatment of: pain.The patient was treated with incontinence medication: palexia for the treatment of: pain.Treatment duration: last year or so.On (b)(6), 2020 the patient commenced psychological medication: ditropan for the treatment of: to stop incontinence.Treatment duration: about 2 years.The patient was treated with physiotherapy treatment (including pelvic floor exercises or training).Additional information received july 7, 2022: it was reported to boston scientific corporation that an obtryx ii system - halo device was implanted into the patient during a vaginal hysterectomy + mid urethral sling + anterior and posterior vaginal repair procedure performed on (b)(6), 2017 for pelvic organ prolapse and stress incontinence.After the vaginal hysterectomy portion of the (b)(6), 2017 procedure whereby the cervix and uterus were removed, the obtryx sling was inserted as per manufacturers instructions and the vaginal mucosa closed with continuous interlocking stitch of 1.0 vicryl.Anterior vaginal repair performed - mucosa plicated with continuous 1.0 vicryl.Posterior vaginal repair performed - mucosa closed with continuous 1.0 vicryl.The patient left the operating theatre in stable condition.Postoperatively, the patient experienced complications and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); back pain; vaginal pain; pelvic pain; groin pain; thigh pain; inability to have intercourse; offensive vaginal discharge; difficulties with bowel motions; recurrent incontinence; aggravated incontinence; damage; psychiatric injury.On (b)(6), 2017 the patient commenced pain medication: lyrica for the treatment of pain; incontinence medication; palexia for the treatment of pain.Treatment duration - last year or so.On (b)(6), 2020 the patient commenced psychological medication ditropan to stop incontinence.Treatment duration: about 2 years.The patient was treated with physiotherapy treatment including pelvic floor exercise or training.

• 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: 12930661
• MDR Text Key: 286512813
• Report Number: 3005099803-2021-07525
• Device Sequence Number: 1
• Product Code: OHD
• 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: 08/03/2022

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 Model Number: 72912
• Device Catalogue Number: 72912
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/10/2021
• Initial Date FDA Received: 12/04/2021
• Supplement Dates Manufacturer Received: 07/07/2022
• Supplement Dates FDA Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 74 YR
• Patient Sex: Female
• Patient Weight: 465 KG