MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS ADVANCE XP SLING SYSTEM; MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE

Model Number 720163-01

Device Problem Use of Device Problem (1670)

Patient Problems Hemorrhage/Bleeding (1888); Complaint, Ill-Defined (2331)

Event Date 01/24/2019

Event Type  Injury  

Event Description

It was reported that the implantation of the advancexp sling caused some additional bleeding as it was being repositioned.The initial position of the advancexp sling was too proximal, and the surgeon therefore repositioned it to a more distal location.The physician believed that this additional bleeding was related to the design of the advancexp sling and the protective tyvek sleeves.The physician reported that the sleeves pulled back when the advancexp sling was positioned to expose the first chevrons closest to the mesh.This pulling back and the exposure of the tyvek sleeves occurred prior to the plastic and tyvek sleeves being cut or removed.The physician felt that this issue caused some additional bleeding at the point where contact was made between the chevrons and the skin.As noted above the tyvek sleeves did not leave any chevrons exposed when the package was initially opened.There did not appear to be a package issue, and the product and package appeared to be correct for the procedure.The surgeon reported that no adverse health effects occurred.The advancexp sling was successfully implanted.

Event Description

It was reported that the implantation of the advancexp sling caused some additional bleeding as it was being repositioned.The initial position of the advancexp sling was too proximal, and the surgeon therefore repositioned it to a more distal location.The physician believed that this additional bleeding was related to the design of the advancexp sling and the protective tyvek sleeves.The physician reported that the sleeves pulled back when the advancexp sling was positioned to expose the first chevrons closest to the mesh.This pulling back and the exposure of the tyvek sleeves occurred prior to the plastic and tyvek sleeves being cut or removed.The physician felt that this issue caused some additional bleeding at the point where contact was made between the chevrons and the skin.As noted above the tyvek sleeves did not leave any chevrons exposed when the package was initially opened.There did not appear to be a package issue, and the product and package appeared to be correct for the procedure.The surgeon reported that no adverse health effects occurred.The advancexp sling was successfully implanted.It was further reported that the patient bleeding was treated with pressure and electrocautery.The bleeding stopped after this intervention was taken.

• Brand Name: AMS ADVANCE XP SLING SYSTEM
• Type of Device: MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752 1242
• MDR Report Key: 8363911
• MDR Text Key: 136930848
• Report Number: 2183959-2019-61048
• Device Sequence Number: 1
• Product Code: OTM
• UDI-Device Identifier: 00878953005560
• UDI-Public: 00878953005560
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/09/2019
• Device Model Number: 720163-01
• Device Catalogue Number: 720163-01
• Device Lot Number: 0022801342
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/24/2019
• Initial Date FDA Received: 02/22/2019
• Supplement Dates Manufacturer Received: 03/14/2019
• Supplement Dates FDA Received: 04/12/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 74 YR