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

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

Patient Problem Death (1802)

Event Date 08/15/2018

Event Type  Death  

Manufacturer Narrative

Majority gender.Average age.Date article accepted journal article title: risk factors for restenosis after drug-coated balloon angioplasty for complex femoropopliteal arterial occlusive disease ann vasc surg 2019; 55: 45¿54.Https://doi.Org/10.1016/j.Avsg.2018.06.015 2018 elsevier inc.All rights reserved.If information is provided in the future, a supplemental report will be issued.

Event Description

This article aims investigate the outcomes of patient treated with dcbs and to identify the predictors of restenosis.It is a retrospective analysis of 120 patients (137 limbs) treated with dcbs for femoropopliteal lesions.There were 80 de novo and 57 in-stent re stenosis lesions treated.Contralateral or ipsilateral femoral puncture was performed, depending on the target lesion location and characteristics.Heparin (5000 u) was administered after vascular access was obtained to achieve an activated clotting time of >250 sec.A 7f sheath was used for the ipsilateral approach, whereas a contralateral sheath (6 to 8f) was applied for the crossover approach.Generally, a 0.018 or 0.035-inch guidewire and a supporting 4/5f multipurpose catheter or microcatheter were used to cross the occluded lesion.Pre-dilatation was systematically performed before treatment with dcb using undersized plain balloon with diameter 1 mm smaller than the reference vessel diameter.Pre-treatment with atherectomy devices such as silverhawk or turbohawk was performed in selected cases in which the lesion was particularly long or heavily calcified, or when the lesion involved the popliteal artery, based on the interventionalist¿s judgment.All patients were treated with in pact admiral dcb systems.Dcb was routinely inflated for 3 min.In cases of flow-limiting dissection or residual stenosis of >50% after additional balloon dilatation, provisional nitinol stents were implanted.After dcb treatment, a combination of antiplatelet agents were routinely administered.Technical success was achieved in all patients.No major complications were observed.There were no cases of major amputations or re intervention at 30 days after the index procedure.The 30-day male (major adverse limb event) was 0%.Eleven patients were lost to follow-up and 3 patients died due to noncardiac causes.The clinical primary patency for the total study population was 85.2% at 1 year and 65.3% at 2 years.The patency of the target lesion was assessed in 67 limbs (48.9%) based on change in rutherford category and abi.The tlr-free survival was 93.0% at 1 year and 87.1% at 2 years.

• Brand Name: BTK TURBOHAWK
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8373162
• MDR Text Key: 137239147
• Report Number: 9612164-2019-00690
• 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: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• 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: 02/11/2019
• 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): Death
• Patient Age: 68 YR