MAUDE Adverse Event Report: CORDIS CORPORATION UNKNOWN ANGIOGUARD; TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE

Model Number AGXXXX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reocclusion (1985)

Event Date 04/01/2002

Event Type  Injury  

Manufacturer Narrative

This complaint was found during a recent clinical evaluation review/literature search of this device.The citation is as follows: kindel, m., & spiller, p.(2002).Transient occlusion of an angioguard protection system by massive embolization during angioplasty of a degenerated aortocoronary saphenous vein graft.Catheterization and cardiovascular interventions, 55(4), 501-504.Complaint conclusion: as noted in the literature publication, kindel et al transient occlusion of an angioguard protection system by massive embolization during angioplasty of a degenerated aortocoronary saphenous vein graft; cathet cardiovasc intervent 2002;55:501¿504; report a case of massive embolization associated with transient occlusion in which larger distal embolization and myocardial infarction were avoided despite transient but complete occlusion of a filter protection system.The product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record review could not be performed.An angioguard filter is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing carotid artery angioplasty and stenting procedures in carotid arteries for patients in which antiplatelet and/or anticoagulant therapy is contraindicated, the guide catheter is unable to be placed, have uncorrected bleeding disorders, known allergies to nitinol, and lesions in the ostium of the common carotid artery.Occlusion of the filter does not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Given the limited information available for review at this time, there is nothing to suggest that the reported event is related to the design and/or manufacturing process of the device; therefore, no corrective action will be taken.Should additional information become available, the file will be updated accordingly.

Event Description

As noted in the literature publication, kindel et al transient occlusion of an angioguard protection system by massive embolization during angioplasty of a degenerated aortocoronary saphenous vein graft; cathet cardiovasc intervent 2002;55:501¿504; report a case of massive embolization associated with transient occlusion in which larger distal embolization and myocardial infarction were avoided despite transient but complete occlusion of a filter protection system.

• Brand Name: UNKNOWN ANGIOGUARD
• Type of Device: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 7266337
• MDR Text Key: 99908238
• Report Number: 1016427-2018-01156
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K062531
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AGXXXX
• Device Catalogue Number: AGXXXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening