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

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

Patient Problems Aneurysm (1708); Perforation (2001); Embolism/Embolus (4438); Restenosis (4576); Insufficient Information (4580)

Event Date 07/12/2021

Event Type  Injury  

Event Description

This retrospective study analyzed 79 patients (83 lesions) who were treated with directional atherectomy (silverhawk and turbohawk) and non-medtronic drug-coated balloon for femoropopliteal lesions.The target limbs were on the left in 36 patients, right in 37, and bilateral in 4.Fourteen patients had previous peripheral revascularization and 10 patients had prior intervention of the target vessel.Forty-four patients were there were 73 limbs with de novo lesion, including 23, 18, and 32 with diffused stenosis, cto, and stenosis + cto, respectively.There were 10 limbs with in-stent restenosis (isr).Target lesions involved the superficial femoral artery, popliteal artery, infrapopliteal artery, and common femoral artery in 65, 39, 5 and 7 patients, respectively.Directional atherectomy was performed at the superficial femoral artery and bifurcation area of the femoral artery in 57 and 7 patients, the p2¿p3 segment of the popliteal artery or proximal area of the infrapopliteal artery in 5 patients, and the p1 segment of the popliteal artery in 28 patients, respectively.The device and procedural success rate were both 100%.All lesions were treated via intraluminal crossing, except for 8 lesions.Retrograde pedal access was used in 3 patients.A distal embolic protection device (spider fx) was deployed in 34 lesions.Before da, 24 lesions were predilated, with a mean balloon diameter of 2.6 mm.The total length of dcb per subject was 230mm.Notably, the rate of bailout stenting was only in this cohort.Infrapopliteal runoff vessel reconstruction was performed in 45 lesions.Four patients had early perioperative complications; 1 puncture site hematoma, 2 distal embolization, 1 perforation.All patients had complete 1-year follow-up data except 2 patients who had no follow-up beyond the day of intervention.During post-procedural year, one patient with a 2-cm popliteal artery diameter was treated with a non-medtronic stent-graft in the degenerated segment.Eight patients experienced a major adverse event; 7 all-cause deaths, 1 major amputation and 1 aneurysm.

Manufacturer Narrative

Average age, majority gender, event date: date of article publication one-year clinical outcome and risk factor analysis of directional atherectomy followed with drug-coated balloon for femoropopliteal artery disease journal of endovascular therapy (2021) 28(6) 927¿937 10.1177/15266028211030527.If information is provided in the future, a supplemental report will be issued.

• Brand Name: BTK TURBOHAWK
• 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 13050899
• MDR Text Key: 286953453
• Report Number: 9612164-2021-04937
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K170191
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• 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: 12/13/2021
• 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: 71 YR
• Patient Sex: Male