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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 Perforation (2001); Obstruction/Occlusion (2422); Vascular Dissection (3160); Embolism/Embolus (4438)
Event Date 07/21/2021
Event Type  Injury  
Manufacturer Narrative
Title: critical appraisal of the contemporary use of atherectomy to treat femoro popliteal atherosclerotic disease author: ryan gupta, sammy siada, samuel lai journal: journal of vascular surgery year: 2022 vol/issue: 75(2) ref: 10. 1016/j. Jvs. 2021. 07. Average age, majority gender, 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 review article was submitted presenting a systematic review and meta-analysis to investigate the outcomes and complications related to atherectomy to treat femoropopliteal atherosclerotic disease. Twenty-four studies encompassing 1900 patients met the inclusion criteria for the present study. Of the 1900 patients, 74. 3% had presented with rutherford class 1 to 3 and 25. 7% presented with rutherford class 4 to 6; 1445 patients had undergone atherectomy, and 455 patients had been treated without atherectomy. The atherectomy group had undergone directional atherectomy (n
=
851), rotational atherectomy (n
=
851), laser atherectomy (n
=
201), and orbital atherectomy (n
=
78). Most of these patients had also received adjunct treatments, which varied across the studies and included a combination of stenting, balloon angioplasty, or drug-coated balloon angioplasty. Within the 24 studies reviewed, medtronic¿s silverhawk and turbohawk devices were identified as directional atherectomy devices used. Technical success was achieved in 92. 3% of the cases. Distal embolization, vessel perforation, and dissection occurred in 3. 4%, 1. 9%, and 4% of the cases, respectively. The initial patency was 95. 4%. At the 12-month median follow-up, the primary patency was 72. 6%. The ankle brachial index had improved from a preoperative mean of 0. 6 to a postoperative mean of 0. 84. The incidence of major amputation and mortality during the follow-up period was 2. 2% and 3. 4%, respectively. There is no established or suspected causal relationship between the device(s) and the death events.
 
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Brand NameATK TURBOHAWK CALCIUM
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
EI
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
EI
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
EI  
091708734
MDR Report Key13507404
MDR Text Key286952753
Report Number9612164-2022-00568
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111723
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2022
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
Date Manufacturer Received02/07/2022
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: 02/10/2022 Patient Sequence Number: 1
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