MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC BARD; ILIAC COVERED STENT, ARTERIAL

Model Number LSMU1350958

Device Problems Difficult to Insert (1316); Difficult to Remove (1528); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946); Foreign Body In Patient (2687); Unspecified Vascular Problem (4441)

Event Date 10/20/2022

Event Type  Injury  

Event Description

Patient was scheduled for bilateral angiogram, which was performed along with an intravascular ultrasound that revealed 75% calcification of the left common iliac artery.Exchanged sheaths to prepare for intervention of the left common iliac artery.Lifestream delivery system was inserted, but the md felt resistance so he removed it at which point the scrub assistant noted that the stent had come off the delivery system.The stent was found under fluoro to be in the l common femoral artery so an attempt was made to snare the stent and retrieve it, but this cinched the stent and it became lodged in the artery.The sheath was removed but the wire, snare, and stent were unable to be removed, but the access site was bleeding.Hemostasis by manual pressure could not be achieved and cut down was necessary to obtain hemostasis.When cut down was performed, the stent was able to be removed by the surgeon, and hemostasis was achieved by suture of the vessel.An abdominal aortagram was performed after hemostasis was achieved and there was no extravasation of the vessel, but there was no flow down the left lower extremity.The patient was transferred to the hospital and arrangements were made to bring the patient straight to the operating room so that flow could be restored and the artery could be patched.Cbc, bmp, pt/inr within normal limits.Fda safety report id #(b)(4).

• Brand Name: BARD
• Type of Device: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC
• MDR Report Key: 15667882
• MDR Text Key: 302480035
• Report Number: MW5112825
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: LSMU1350958
• Device Catalogue Number: LSMU1350958
• Device Lot Number: CMFQ0369
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White