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

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

Patient Problems Embolism/Embolus (4438); Restenosis (4576); Insufficient Information (4580)

Event Date 10/28/2021

Event Type  Injury  

Manufacturer Narrative

Title: author: journal: year: vol/issue.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted detailing a review focused on the following three technologies aimed at challenging, high-risk lesions: intravascular lithotripsy, atherectomy, and drug-coated devices.The highest quality of available data for each device was selected for review, with priority given to randomized controlled trials (rcts), but often relying on single-arm prospective cohorts or registries.The review identifies medtronic¿s silverhawk, turbohawk, and hawkone directional atherectomy devices.The article identified 3 major clinical trials in which the silverhawk and/or turbohawk devices were used.Two of the trials identified were the definitive le and definitive ar trials which were sponsored by medtronic endovascular.The remaining study related to the silverhawk device involving a population of intermittent claudication (ic) and critical limb threatening ischemia (clti) (rutherford 1 to 5), sfa to tibial, de novo lesions.At least one vessel runoff and severe calcification were excluded.Target limb reintervention (tlr) reported for this study at 12 months: 11.1% for da (directional atherectomy) + pba (plain balloon angioplasty) v 16.7% for pba alone.Adverse events reported include embolization: 64.7% in da + pba v 0% in pba alone when a filter was used.Stent rate: 27.6% in da + pba v 62% in pba alone.Related to drug-coated devices, medtronic¿s inpact admiral and in.Pact amphirion drug-coated balloons are identified.The article identified 2 major clinical trials in which the inpact admiral and in.Pact amphirion drug-coated balloons were used; in.Pact sfa, and in.Pact deep respectively both of which were sponsored by medtronic endovascular.

• Brand Name: SILVERHAWK BTK
• 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: 13649387
• MDR Text Key: 286423032
• Report Number: 9612164-2022-00837
• 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: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2022
• 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: 02/08/2022
• 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