MAUDE Adverse Event Report: COVIDIEN LP SPIDERFX; TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE

Model Number	SPD2-US-030-320
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/28/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient went to the cardiac cath lab for planned right and left heart catheterization due to her sub-total occlusion of her right coronary artery.A stent had initially been partially deployed to the right coronary artery with a spiderfx wire filter device for distal embolic protection, given the large thrombus burden at risk of embolization.Due to difficulty passing post-dilatation balloons for final stent expansion, a decision was made to proceed to remove the spiderfx wire filter.The capture sheath of the filter spiderfx wire became caught on the proximal edge of the stent and then the stent, filter wire and capture sheath were removed from the coronary artery.The capture sheath was then removed from the body.However, the proceduralist was unable to remove the stent-filter combination through the femoral sheath.During the device removal, the distal wire broke off and under fluoroscopy the capture wire segment containing the stent and filter could be visualized as having migrated to the common femoral artery bifurcation.The proceduralist immediately called for vascular interventional cardiologist and a vascular surgeon to the cath lab procedure room.The proceduralist was able to obtain adequate hemostasis at the right femoral artery site with the existing sheath and manual compression, and then finished the right coronary artery stenting procedure with successful placement of 1 stent.The patient was moved directly to the operating room where the vascular surgeon performed surgical removal of the foreign object (broken stent, filter, and capture wire) via right groin exploration, embolectomy and angiogram.Per the proceduralist md "there was no specific device malfunction.This was due to angle of devices interacting with the deployed stent, due to the patient's coronary anatomy.".

• Brand Name: SPIDERFX
• Common Device Name: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 7120527
• Report Number: 7120527
• Device Sequence Number: 1260451
• Product Code: NTE
• UDI-Device Identifier: 00821684068304
• UDI-Public: (01)00821684068304
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/12/2017
• Report Date (Section F): 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 06/09/2018
• Device Model Number: SPD2-US-030-320
• Device Catalogue Number: SPD2-US-030-320
• Device Lot Number: A292273
• Was the Report Sent to FDA?: Yes
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 12/04/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SY
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 87 YR
• Date Report Sent to FDA: 12/04/2017