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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); Perforation (2001); Injury (2348)
Event Date 04/03/2020
Event Type  Injury  
Manufacturer Narrative
Journal title: comparison of long term outcomes after directional versus rotational atherectomy in peripheral artery disease journal: advances in interventional cardiology year: 2020 ref: doi: 10.5114/aic.2020.93914.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
This literature article reports on the long-term outcomes after pad endovascular revascularization with two types of atherectomies: rotational atherectomy (non-medtronic device) and directional with medtronic¿s silverhawk device.This is a retrospective study of patients with obstructive and symptomatic pad who underwent revascularization with atherectomy.The endpoints were considered as target lesion revascularization (tlr), death, amputations and bailout stenting (bs).The atherectomy device type was left to the discretion of the physician.Atherectomy was followed by low-pressure balloon post-dilatation if residual stenosis was > 30%.A distal protection system was not used for any patients.Angiographic success was defined as post-procedural timi 3 flow, no dissection and residual stenosis <(><<)> 30%.If angiographic success was not achieved, bail-out stenting was performed.Aspirin (81 mg/day) was continued indefinitely whereas clopidogrel (75 mg/day) was advised to be continued for 12 months after the procedure, as well as atorvastatin at the maximum tolerable dose, usually 40 mg daily.In both groups the primary lesion location was the anterior tibial artery.The number of periprocedural complications was low and similar between groups.The tlr was significantly more frequent in the directional atherectomy group (29%) than in rotational atherectomy group (15%).There were no significant differences in time to tlr, amputation or death rate between the groups.Peri-procedural complications are reported as artery perforation, flow limiting dissection, bailout stenting, and amputation.Death is reported in 1.7% of cases.There were are 182 patients in this study with 85 in the directional atherectomy treatment group.Post procedural outcome reported for this group are perforation, dissection, periprocedural death and bailout stenting.
 
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Brand Name
SILVERHAWK BTK
Type of Device
CATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
IE 
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
IE  
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
IE  
091708734
MDR Report Key10283118
MDR Text Key199319696
Report Number9612164-2020-02623
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
K061188
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 07/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/06/2020
Initial Date FDA Received07/16/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age71 YR
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