MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPSYLON; MESH, SURGICAL, SYNTHETIC

Model Number M0068318200

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

Patient Problems Erosion (1750); Fever (1858); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling (2091); Urinary Retention (2119); Urinary Tract Infection (2120); Urinary Frequency (2275); Injury (2348); Numbness (2415); Prolapse (2475); Dysuria (2684); Constipation (3274)

Event Date 02/15/2018

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The voluntary user medwatch number is mw5080822.The removed mesh 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.

Event Description

Note: this manufacturer report pertains to one of two devices used during the same procedure.It was reported to boston scientific corporation that an upsylon y-mesh and an obtryx halo sling were implanted during a pelvic organ prolapse procedure performed on (b)(6) 2017.According to the complainant, in 2018, she went to see the physician who implanted the device due to severe pain and the stitches that she felt were coming out from her vagina with blood spotting.She also reported to have dyspareunia.The patient gave a urine sample for laboratory and results showed that she has urinary tract infection, bladder infection.She also reported that the physician examined her vagina and told her that some mesh were pushing through on the back of the vaginal wall.Subsequently, the physician put her to sleep and performed an in-office procedure by cutting out the mesh that was eroding from the patient's body.The patient reported that she had the anesthesiologist and nurse aid during this in-office procedure.She was also prescribed with macrobid.She went back to the physician for her scheduled post-operative check-up and the physician is no longer part of her insurance and cost her huge amount of money considering it was not a hospital surgery.Furthermore, she reported that she is still experiencing bladder infection, difficulty to urinate and mesh erosion.She still has severe vaginal/pelvic pain and bleeding, and sexual intercourse was impossible.She stated that she is concerned about all of her vessels, nerves, structures and organs, including her bladder, urethra and bowels.The mesh extrusion, exposure or erosion into her vagina felt like it had invaded her other structures and organs.She has voiding dysfunction and pain during intercourse which has almost destroyed her marriage for 30 years.Neuromuscular problems, acute and chronic pain in her groin, thighs, legs, pelvic abdominal areas and numbness on the legs are also experienced by the patient.Reportedly, her lower back pain was off the chart.She reportedly does not take any pain medication.She has urinary frequency during sleeping hours that never happened before her surgery.She only had the surgery due to urinary retention.In addition, she experienced various allergic reactions like stiffness, swelling, aches in her joints and blisters like nodules developed on her finger joints that lasted for months.The blisters like nodules finally exploded.She believes that it could be an allergic reaction to the mesh.She developed severe constipation, defecation dysfunction that is painful, and her vagina hurts every time she goes to the bathroom.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

• Brand Name: UPSYLON
• Type of Device: MESH, SURGICAL, SYNTHETIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): PROXY BIOMEDICAL; coilleach; spiddal, co galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 8153199
• MDR Text Key: 130025281
• Report Number: 3005099803-2018-61817
• Device Sequence Number: 1
• Product Code: OTO
• UDI-Device Identifier: 08714729839217
• UDI-Public: 08714729839217
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122794
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M0068318200
• Device Catalogue Number: 831-820
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention