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

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

Patient Problems Embolism (1829); Hematoma (1884); Occlusion (1984); Perforation (2001); Injury (2348)

Event Date 04/25/2020

Event Type  Injury  

Manufacturer Narrative

Journal title: outcomes of adjunctive drug-coated versus uncoated balloon after atherectomy in femoropopliteal artery disease journal: annals of vascular surgery year: 2020 ref: doi: 10.1016/j.Avsg.2020.04.032.Date of event: 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 a single-center retrospective and prospective study to evaluate outcomes using drug-coated balloon (dcb) in comparison with uncoated balloon as adjunctive treatment after atherectomy for femoropopliteal artery lesions.115 patients with 126 limbs treated were included in the study.Medtronic¿s atherectomy device¿s silverhawk, turbohawk, and hawkone were used as well as medtronic¿s in.Pact admiral paclitaxel-coated balloon and medtronic¿s spider fx distal embolization protection devices during the procedure.Clinical event¿s including vascular perforations, device entrapment by stent (requiring surgical repair), flow-limiting embolization, and access site access site hematoma were reported in the population as immediate procedural outcomes.Complications were management by surgical management or conservative care.Long-term clinical outcomes reported include in-stent restenosis (isr) and target lesion revascularization (tlr).Death is reported, however no device or procedural relationship has been identified.

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: ATK TURBOHAWK CALCIUM
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 10749603
• MDR Text Key: 216673784
• Report Number: 9612164-2020-04117
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• PMA/PMN Number: K170191
• 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: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• 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: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR