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

Device Problems Entrapment of Device (1212); Use of Device Problem (1670)

Patient Problem 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.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 protectiondevices 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.

• Brand Name: ATK TURBOHAWK CALCIUM
• 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: 10749916
• MDR Text Key: 215531236
• Report Number: 9612164-2020-04122
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K170191
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/28/2020

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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2020
• 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: 68 YR