MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. LIFESTENT; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	5F061003CS
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During stent placement of the left fem-pop, the deployment mechanism fractured.Dr.Then snared the mechanism, stent left in place.Per physician's note: the first stent i used was at the above-knee popliteal artery, which was a bard lifestent, 6 x 100.Interestingly, the first attempt at stenting failed due to mechanical device failure of the stent deployment mechanism.I did not even deploy the stent, but the deployment mechanism dislodged and fractured and embolized into the superficial femoral artery.Just before i even inserted the stent into any atheroma or even attempted to traverse it through any lesion, it had intrinsic failure.I was able to successfully snare this device and remove the entire device with no further foreign body noted from this device.

• Brand Name: LIFESTENT
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w. 3rd st; tempe AZ 85281
• MDR Report Key: 13440428
• Report Number: 13440428
• Device Sequence Number: 4327383
• Product Code: NIP
• UDI-Device Identifier: 00801741120183
• UDI-Public: (01)00801741120183(17)240917(10)ANFW1847
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/01/2022
• Report Date (Section F): 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5F061003CS
• Device Catalogue Number: 5F061003CS
• Device Lot Number: ANFW1847
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 105 KG
• Patient Race: White
• Date Report Sent to FDA: 02/01/2022