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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN HAWKONE CATHETER, PERIPHERAL, ATHERECTOMY

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COVIDIEN HAWKONE CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Obstruction/Occlusion (2422); Thromboembolism (2654); Vascular Dissection (3160)
Event Date 12/06/2020
Event Type  Injury  
Manufacturer Narrative
Title: embolic protection in complex femoropopliteal interventions: safety, efficacy and predictors of filter macroembolization authors: michael czihal, zeynep findik, christoph bernau journal: cardiovascular interventional radiology year: 2020, ref: 10. 1007/s00270-020-02717-w, average age, majority gender, date of publication. If information is provided in the future, a supplemental report will be issued.
 
Event Description
A journal article was submitted detailing a study of ¿embolic protection in complex femoro popliteal interventions: safety, efficacy and predictors of filter macro embolization. ¿ to evaluate the safety and efficacy of a filter embolic protection device (fepd) in endovascular interventions of the femoropopliteal arteries. 244 cases were identified and 203 patients were included in the study.   balloon angioplasty ± stenting (bap), directional atherectomy ± balloon angioplasty ± stenting (da) and rotational thrombectomy ± balloon angioplasty ± stenting (rt) were performed in 141, 61 and 42 cases, respectively. Standard balloon catheters were used for bap. Da was carried out with devices of the hawk-family. Rt was carried out using a non-medtronic device. Spider fx was used as embolic protection. Permanent filter-related vessel damage was not observed. However, vasospasm at the filter site requiring intra arterial spasmolysis with nitroglycerine occurred in 11 cases. Revascularization failed in eight cases (3. 3%), including two patients with primary technical failure and one patient in whom perforation of the popliteal artery following rt required urgent surgical revascularization. Despite filter protection, peripheral embolization distal to the fedp occurred in ten cases , including nine total occlusions. In eight of the ten cases with peripheral embolization distal to the fedp, macroemboli were also found in the filter basket. Treatment consisting of aspiration thrombectomy and/or thrombolysis was successful in nine of the ten cases. Permanent filter-related vessel damage was not observed.
 
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Brand NameHAWKONE
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
EI  
091708734
MDR Report Key11177504
MDR Text Key227047198
Report Number2183870-2021-00027
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K161361
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 01/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/06/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/15/2021 Patient Sequence Number: 1
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