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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND ATK TURBOHAWK CALCIUM CATHETER, PERIPHERAL, ATHERECTOMY

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MEDTRONIC IRELAND ATK TURBOHAWK CALCIUM CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Embolism (1829); Hematoma (1884); Occlusion (1984); Perforation (2001); Injury (2348)
Event Date 04/25/2020
Event Type  Injury  
Manufacturer Narrative
Journal title: outcomes of adjunctive drug-coated versus uncoated balloon after atherectomy in femoropopliteal artery disease journal: annals of vascular surgery year: 2020 ref: doi: 10. 1016/j. Avsg. 2020. 04. 032. Date of event: 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 a single-center retrospective and prospective study to evaluate outcomes using drug-coated balloon (dcb) in comparison with uncoated balloon as adjunctive treatment after atherectomy for femoropopliteal artery lesions. 115 patients with 126 limbs treated were included in the study. Medtronic¿s atherectomy device¿s silverhawk, turbohawk, and hawkone were used as well as medtronic¿s in. Pact admiral paclitaxel-coated balloon and medtronic¿s spider fx distal embolization protection devices during the procedure. Clinical event¿s including vascular perforations, device entrapment by stent (requiring surgical repair), flow-limiting embolization, and access site access site hematoma were reported in the population as immediate procedural outcomes. Complications were management by surgical management or conservative care. Long-term clinical outcomes reported include in-stent restenosis (isr) and target lesion revascularization (tlr). Death is reported, however no device or procedural relationship has been identified.
 
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Brand NameATK TURBOHAWK CALCIUM
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 Key10749603
MDR Text Key216673784
Report Number9612164-2020-04117
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K170191
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2020
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 Received10/15/2020
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: 10/28/2020 Patient Sequence Number: 1
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