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 Incontinence (1928); Pain (1994); Abnormal Vaginal Discharge (2123); Prolapse (2475); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 12/03/2019

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a upsylon y-mesh was implanted into the patient on (b)(6) 2008.A second upsylon y-mesh implant was implanted into the patient on (b)(6) 2019.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: back pain; vaginal pain; pelvic pain; groin pain; perin pain; anal pain; rect pain; thi pain; pain inter; inab inter; off vag dis; diff bowel; incont not pres; rec incont; aggrav incont; psych; oth pain: headaches, pain all over surgical interventions: on (b)(6) 2019 the patient underwent further surgery regarding the upsylon y-mesh implant under general anesthesia for the following purpose: prolapse again even after first mesh implant and sling.Nonsurgical treatments: on (b)(6)1997 the patient commenced pain medication: panadol and aspirin for the treatment of: pain.Treatment duration: ongoing whole life to try and cope with pain.On (b)(6) 2021 the patient commenced incontinence medication: oxybutynin for the treatment of: bladder spasms treatment.Treatment duration: for the rest of my life.On (b)(6) 2019 the patient commenced other medication (please specify): ovestin suppository for the treatment of: avoiding infection since surgery.Treatment duration: 3 times a week from(b)(6) 2019 until (b)(6) 2021.On (b)(6) 2020 the patient commenced physiotherapy treatment (including pelvic floor exercises or training) for the treatment of: pain and discomfort exercises.Treatment duration: for the rest of my life.On (b)(6) 2021 the patient commenced topical treatment (including oestrogen cream): ovestin cream for the treatment of: avoiding infection and keeping moisture avoiding dryness and discomfort.Treatment duration: for the rest of my life 3 times a week cream instead of suppository.The patient was treated with other (please specify) for the treatment of: prolapse still falling.Treatment duration: for rest of my life.

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.

Manufacturer Narrative

Block a1: (b)(4).Block d4, h4: 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.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.

Event Description

Note: this report pertains to the second of two upsylon y-mesh devices implanted into the same patient.It was reported to boston scientific corporation that a upsylon y-mesh was implanted into the patient on (b)(6) 2008.A second upsylon y-mesh implant was implanted into the patient on (b)(6) 2019.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: back pain; vaginal pain; pelvic pain; groin pain; perineum pain; anal pain; rectal pain; thigh pain; painful intercourse; inability to have intercourse; offensive vaginal discharge; difficulties with bowel motions; incontinence not present before implant; recurrent incontinence; aggravated incontinence; psychiatric injury; other pain: headaches, pain all over.Surgical interventions: on (b)(6) 2019 the patient underwent further surgery regarding the first upsylon y-mesh implant under general anesthesia for the following purpose: prolapse again even after first mesh implant and sling.Nonsurgical treatments: on (b)(6) 1997 the patient commenced pain medication: panadol and asprin for: pain.Treatment duration: ongoing whole life to try and cope with pain.On (b)(6) 2021 the patient commenced incontinence medication: oxybutynin for: bladder spasms treatment.Treatment duration: for the rest of patient's life.On (b)(6) 2019 the patient commenced other medication (please specify): ovestin suppository for purpose: avoiding infection since surgery.Treatment duration: 3 times a week from (b)(6) 2019 until (b)(6) 2021.On (b)(6) 2020 the patient commenced physiotherapy treatment (including pelvic floor exercises or training) for purpose: pain and discomfort exercises.Treatment duration: for the rest of patient's life.On (b)(6) 2021 the patient commenced topical treatment (including oestrogen cream): ovestin cream for the treatment of: avoiding infection and keeping moisture avoiding dryness and discomfort.Treatment duration: for the rest of patient's life 3 times a week cream instead of suppository.The patient was treated with pessary for purpose: prolapse still falling.Treatment duration: for rest of patient's life.

• 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: 12930821
• MDR Text Key: 286647012
• Report Number: 3005099803-2021-06925
• 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: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2021
• 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
• Date Manufacturer Received: 12/06/2021
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 66 KG