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

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stenosis (2263); Embolism/Embolus (4438)

Event Date 07/15/2020

Event Type  Injury  

Manufacturer Narrative

Title: directional atherectomy for treating in-stent restenosis of the superficial femoral artery authors: seung-kee min, ahram han, sang-hyun ahn journal: vascular specialist international year: 2020 vol/issue: 36(3) ref: 0000-0002-1433-2562.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted detailing a retrospective cross-sectional study among patients with in-stent restenosis (isr) in the superficial femoral artery (sfa).257 limbs in 253 patients underwent stent insertion for superficial femoral artery lesions.Medtr onic¿s complete se stent was used during treatment.73 limbs of 73 patients were excluded due to multiple lesion in index vessels, previous stenting history in index vessels and follow-up loss after the procedure.The clinical record of 180 patients (184 limbs) was reviewed.29 limbs in 27 patients diagnosed as in-stent restenosis.14 limbs underwent atherectomy followed by balloon angioplasty.15 limbs underwent balloon angioplasty alone.Medtronic¿s silverhawk atherectomy device was used for atherectomy.One patient in the atherectomy group, and 4 patient¿s in the balloon angioplasty group were treated with an inpact admiral.Technical success was achieved in all patients in both groups, and procedural success was achieved in 85.7% of the atherectomy group, and 73.3% of the angioplasty group, with no significant differences.Clinical events of residual stenosis (treated by repeated balloon angioplasty), distal embolization (treated by aspiration embolectomy), and flow-limiting dissection (treated by bailout stenting) are reported as outcomes following treatment.At one-year follow-up target lesion revascularization was carried out across the two groups.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SILVERHAWK BTK
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 11025657
• MDR Text Key: 223611811
• Report Number: 9612164-2020-04953
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• PMA/PMN Number: K061188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR