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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND SILVERHAWK BTK CATHETER, PERIPHERAL, ATHERECTOMY

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MEDTRONIC IRELAND SILVERHAWK BTK CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Intimal Dissection (1333); Stroke/CVA (1770); Embolism (1829); Reocclusion (1985); Renal Failure (2041)
Event Date 09/04/2020
Event Type  Injury  
Manufacturer Narrative
Title: two-year outcomes of endovascular interventions of the common femoral artery: a retrospective analysis from two medical centers journal: cardiovascular revascularization medicine year: 2020 issue: s1553-8389(20)30548-0. Ref: doi: 10. 1016/j. Carrev. 2020. 09. 006. Date of publication journal reported death but there is no information to suggest the device caused or contributed to the death events. Deaths are common occurrences in clinical studies, however the cause(s) of death are often not characterized or clearly associated with a particular product. Therefore, deaths will not be considered reportable unless clearly stated as being associated with a medtronic device. If information is provided in the future, a supplemental report will be issued.
 
Event Description
A journal article was submitted detailing study of "two-year outcomes of endovascular interventions of the common femoral artery: a retrospective analysis from two medical centers". Spider embolic protection device, turbohawk and hawkone directional atherectomy devices were the medtronic devices used in the procedures. Clinical event outcomes reported are dissection, distal embolization requiring treatment, unplanned minor or major amputation, in-hospital mortality (stroke), non-fatal myocardial infarction, access site complication, acute closure, stenting of the common femoral artery, bailout stenting, in-hospital acute renal failure, major bleeding and in hospital target lesion revascularization. Target lesion revascularization, target vessel revascularization, unplanned major amputation and death were reported at 1 year and 2 year follow up. Mortality occurred in 8 patients during follow up and was not procedural related.
 
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Brand NameSILVERHAWK BTK
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
 
091708734
MDR Report Key10801038
MDR Text Key215041378
Report Number9612164-2020-04299
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K061188
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 11/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2020
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 Received10/08/2020
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: 11/06/2020 Patient Sequence Number: 1
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