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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stenosis (2263); Vascular Dissection (3160)

Event Date 03/01/2018

Event Type  Injury  

Event Description

Medtronic received a literature article reporting a retrospective review the records of consecutive patients with eligible cfa lesions who were treated with endovascular methods between 2011 and 2013.Ninety patients with cfa lesions were treated, and 76 (84.4%) completed a follow-up.Angioplasty was performed in 45 patients, and atherectomy was performed in 31 patients.Atherectomy was performed using the silverhawk/turbohawk directional atherectomy device.Distal protection devices used included spiderfx.Angioplasty was performed using conventional none drug-eluting balloon angioplasty.There was one case of dissections in the atherectomy group, no treatment required.Technical success was 100%.After 4 years, primary patency in patients treated with atherectomy was 87.1%.

Manufacturer Narrative

Literature ref: doi.Org/10.1016//j.Avsg.2017.12.004.A2: average age.A3: majority sex.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: SILVERHAWK ATK
• Type of Device: CATHETER, 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 19031934
• MDR Text Key: 339235562
• Report Number: 9612164-2024-01574
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K061188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 04/03/2024
• 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 Age: 67 YR
• Patient Sex: Male