MAUDE Adverse Event Report: COOK MEDICAL LLC COOK ZILVER PTX 6 MM X 40 MM STENT; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Device Problem Premature Activation (1484)

Patient Problem Thrombosis (2100)

Event Date 10/09/2019

Event Type  malfunction  

Event Description

Pt had ir thrombolysis during which time a stent was advanced through the sheath and prematurely deployed.Advancement was aborted.Retrieval of the stent was successful, but 3-4 of the distal times of the stent sheared off around the left common femoral artery, likely extravascular.Fda safety report id# (b)(4).

• Brand Name: COOK ZILVER PTX 6 MM X 40 MM STENT
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK MEDICAL LLC
• MDR Report Key: 9728806
• MDR Text Key: 180362830
• Report Number: MW5093071
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/13/2020

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
• Device Operator: No Information
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/18/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR