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); Abnormal Vaginal Discharge (2123); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Insufficient Information (4580)

Event Date 10/05/2016

Event Type  Injury  

Event Description

Note: two boston scientific mesh devices were implanted in the same patient.This report pertains to the upsylon y-mesh.It was reported to boston scientific corporation that an upsylon y-mesh and an advantage fit were implanted into the patient on (b)(6) 2016.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; perineum pain; anal pain; rectal pain; thigh pain; painful intercourse; inability to have intercourse; offensive vaginal discharge; difficulties with bowel motions; recurrent incontinence; aggravated incontinence; damage; psychiatric 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

Note: two boston scientific mesh devices were implanted in the same patient.This report pertains to the upsylon y-mesh.It was reported to boston scientific corporation that an upsylon y-mesh and an advantage fit system were implanted into the patient during an anterior and posterior repair, sacrospinous hitch, insertion of tension-free vaginal tape and cystoscopy procedure performed on (b)(6) 2016, for the treatment of prolapse and stress urinary incontinence.The patient experienced complications and nonsurgical treatment.The prolapse surgery involved a moderate-sized anterior and then a larger posterior repair incorporating sacrospinous hitch, the latter to anchor the vaginal vault to the strong sacrospinous ligament of the sidewall of the pelvis.An excellent anatomical result was achieved.The second part of the procedure was the insertion of a tension-free vaginal tape.The combined procedure was performed under spinal block to allow intraoperative tensioning of the tape.The patient was perfectly dry at the end of the cough testing.Additionally, cystoscopy revealed no particular abnormality.A suprapubic catheter was inserted.She was progressing well in the early postoperative phase.As reported by the patient's attorney, the patient's symptoms include: eep (erosion/extrusion/protrusion of the mesh); 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; recurrent incontinence; aggravated incontinence; damage; and psychiatric injury.

Manufacturer Narrative

Additional information to blocks a1: patient's initials, b5, and e1: physician's name and healthcare facility.Block a1: (b)(6).Block b3 date of event: date of event was approximated to (b)(6) 2016, the date the sling was implanted, as no event date was reported.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 e1: this event was reported by the patient's legal representative.The implant surgeon is: dr.(b)(6), australia, phone number: (b)(6), fax number: (b)(6).Dr.(b)(6), australia.Block h6: patient codes e2006, e2330, e1405, and e0206 capture the reportable events of erosion (extrusion, protrusion of the mesh), pain (back pain, vaginal pain, pelvic pain, groin pain, perinuem pain, anal pain, rectal pain, thigh pain, painful intercourse), dyspareunia (inability to have intercourse), and unspecified mental, emotional or behavioral problem (psychiatric injury).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 failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• 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: 12926136
• MDR Text Key: 285999768
• Report Number: 3005099803-2021-06472
• 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: 08/02/2022

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 Model Number: M0068318220
• Device Catalogue Number: 72912
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/07/2022
• 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: 33 YR
• Patient Sex: Female
• Patient Weight: 60 KG