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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Perforation of Vessels (2135)

Event Date 11/30/2021

Event Type  Injury  

Event Description

It was reported that during the implant surgery of the advance xp sling the physician was tensioning the device and an unanticipated bleeding occurred.The unanticipated bleeding was believed to be a result of tensioning the sling and rupturing a vessel.The physician used a clotting sponge to control bleeding.The quick clotting sponges were left inside of the patient and the procedure was completed successfully.The patient is expected to fully recover.

Event Description

It was reported that during the implant surgery of the advance xp sling the physician was tensioning the device and an unanticipated bleeding occurred.The unanticipated bleeding was believed to be a result of tensioning the sling and rupturing a vessel.The physician used a clotting sponge to control bleeding.The quick clotting sponges were left inside of the patient and the procedure was completed successfully.The patient is expected to fully recover.

Manufacturer Narrative

Investigation summary: based on the information available, boston scientific concludes that the cause that contributed to the reported event cannot be established as the product is not available for analysis.Device history record review: the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Device technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Without a returned product available for analysis and based on this investigation a clear probable cause for the event cannot be established.Labeling review: a review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.There is no objective evidence that the user did not properly handle or use the device according to the sling mens instructions for use (ifu).The sling mens ifu lists bleeding and perforation vessel as potential adverse events associated with implant of this device.Investigation conclusion: based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.

Manufacturer Narrative

Investigation summary: based on the information available, boston scientific concludes that the cause that contributed to the reported event cannot be established as the product is not available for analysis.Device history record review: the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Device technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Without a returned product available for analysis and based on this investigation a clear probable cause for the event cannot be established.Labeling review: a review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.There is no objective evidence that the user did not properly handle or use the device according to the sling mens instructions for use (ifu).The sling mens ifu lists bleeding and perforation vessel as potential adverse events associated with implant of this device.Investigation conclusion: based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.

Event Description

It was reported that during the implant surgery of the advance xp sling the physician was tensioning the device and an unanticipated bleeding occurred.The unanticipated bleeding was believed to be a result of tensioning the sling and rupturing a vessel.The physician used a clotting sponge to control bleeding.The quick clotting sponges were left inside of the patient and the procedure was completed successfully.The patient is expected to fully recover.

• Brand Name: AMS ADVANCE XP SLING SYSTEM
• Type of Device: MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 4089353452
• MDR Report Key: 13025082
• MDR Text Key: 282388202
• Report Number: 2124215-2021-38195
• Device Sequence Number: 1
• Product Code: OTM
• UDI-Device Identifier: 00878953005560
• UDI-Public: 00878953005560
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2022

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 Expiration Date: 01/12/2022
• Device Model Number: 720163-01
• Device Catalogue Number: 720163-01
• Device Lot Number: 0026850288
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2021
• Initial Date FDA Received: 12/17/2021
• Supplement Dates Manufacturer Received: 12/27/2021; 01/26/2022
• Supplement Dates FDA Received: 12/29/2021; 01/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2021
• 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: 69 YR
• Patient Sex: Male
• Patient Race: White