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

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.

• 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 Key: 10283118
• MDR Text Key: 199319696
• Report Number: 9612164-2020-02623
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K061188
• Number of Events Reported: 1
• 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 Received: 07/16/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR