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); 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.

• 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: 10801038
• MDR Text Key: 215041378
• Report Number: 9612164-2020-04299
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• 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 Received: 11/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2020
• 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: 65 YR