MAUDE Adverse Event Report: COVIDIEN (IRVINE) HAWKONE; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number UNK-PLY-HAWKONE

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

Patient Problems Embolism (1829); Hematoma (1884); Occlusion (1984); Reocclusion (1985); Perforation (2001); Pseudoaneurysm (2605)

Event Date 12/23/2016

Event Type  Injury  

Manufacturer Narrative

Age at event: mean age.Date of event: estimate of when events began title of article: directional atherectomy with antirestenotic therapy vs drug-coated balloon angioplasty alone for isolated popliteal artery lesions journal of endovascular therapy 2017, vol.24(2) 181-188 doi: 10.1177/1526602816683933 www.Jevt.Org.(b)(4).

Event Description

A study was conducted to report a single-center study comparing drug-coated balloon (dcb) angioplasty vs directional atherectomy with antirestenotic therapy (daart) for isolated lesions of the popliteal artery.Seventy-two (72) symptomatic pad patients with an average age of 72 years, with a history of hypertension, diabetes mellitus, dyslipidemia, coronary heart disease, chronic kidney disease and cerebrovascular disease.The patients were treated at a single center between october 2009 and december 2015 for isolated popliteal lesions.In.Pact admiral, in.Pact pacific, spider, turbohawk, silverhawk, hawkone atherectomy devices were used for the procedures.The dcb patients presented with distal embolization, perforated vessel wall, false aneurysm, hematoma and target lesion revascularization (tlr).The daart patients presented with distal embolization, perforated vessel wall, false aneurysm, hematoma, tlr, aneurysm, re-occlusion, 1 patient died of unknown causes.Additionally, physician reported that the death of 1 patient was not related to the daart procedure.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: HAWKONE
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6639830
• MDR Text Key: 77529582
• Report Number: 2183870-2017-00254
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K141801
• 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,Followup
• Report Date: 05/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-PLY-HAWKONE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2017
• Was Device Evaluated by Manufacturer?: No
• 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: 72 YR