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 Embolism (1829)

Event Date 06/25/2003

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: konig, c.W.(2003).Frequent embolization in peripheral angioplasty: detection with an embolism protection device (angioguard) and electron microscopy.Cardiovascular and interventional radiology, 26(4), 334-339.Complaint conclusion: as noted in the literature publication, konig et al frequent embolization in peripheral angioplasty: detection with an embolism protection device (angioguard) and electron microscopy, cardiovasc intervent radiol (2003) 26:334¿339; embolization associated with filter deployment was demonstrated in a minimum of two of five patients.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.The safety and effectiveness of this device as an emboli protection system has not been established in the coronary, cerebral, or peripheral vasculature, other than carotid arteries.Embolism 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, konig et al frequent embolization in peripheral angioplasty: detection with an embolism protection device (angioguard) and electron microscopy, cardiovasc intervent radiol (2003) 26:334¿339; embolization associated with filter deployment was demonstrated in a minimum of two of five patients.

• 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: 7151993
• MDR Text Key: 95958271
• Report Number: 1016427-2017-00924
• 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: 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• 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: 11/28/2017
• 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