MAUDE Adverse Event Report: EV3, INC. SPIDER FX EMBOLIC PROTECTION DEVICE; TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION

Lot Number A333547

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528); Sticking (1597)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/17/2016

Event Type  malfunction  

Event Description

At the end of a peripheral atherectomy procedure, when removing the spiderfx embolic protection device, the filter basket became stuck and pulled off the delivery wire.The filter basket was left in the left femoral artery.Md contacted a vascular surgeon for consult and to remove the filter basket via cutdown.The patient was admitted to medical telemetry until transfer to a sister hospital for surgical removal of the filter basket.

• Brand Name: SPIDER FX EMBOLIC PROTECTION DEVICE
• Type of Device: TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION
• Manufacturer (Section D): EV3, INC.; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 6092109
• MDR Text Key: 59581933
• Report Number: 6092109
• Device Sequence Number: 1
• Product Code: NFA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: A333547
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/08/2016
• Event Location: Hospital
• Date Report to Manufacturer: 11/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR