MAUDE Adverse Event Report: MEDTRONIC IRELAND IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

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

Patient Problem Stenosis (2263)

Event Date 11/26/2019

Event Type  Injury  

Manufacturer Narrative

Event date: date of article publication (i.E.Event date is literature article published date) comparison of drug-coated balloon treatment of femoropopliteal artery disease annals of vascular surgery (2019) 61;19-20 10.1016/j.Avsg.2019.10.026.If information is provided in the future, a supplemental report will be issued.

Event Description

This article reports a retrospective review of prospectively enrolled, consecutive patients who underwent dcb angioplasty.Treatment sites included the superficial femoral artery and popliteal artery.Data collection included demographics, comorbidities, indication for treatment (rutherford class), treatment length (mm), patency, target lesion revascularization (tlr), vessel diameter, brand of device used, calcification of target vessel, wound healing data, and amputation free survival (afs) at 12 months (m).A total of 61 limbs were treated in 57 patients: 32 with claudication and 29 with cli.Primary patency at 6 m, 12 m, and 24 m was 80%, 69% and 52%, respectively.For comparison, 12 and 24 m patency for a non-medtronic dcb was 65% and 59% and similarly 83% and 79% for the medtronic in.Pact dcb, respectively.There was no difference in patency in regard to device brand, sex, treated vessel luminal diameter, or calcification.Average target lesion length was 153 mm, and median was 120 mm.Patent arteries at 12 m had a median treated segment length of 120 mm vs 220 mm for those that were not patent.Of note, all treated lesions treated less than 100 mm were patent at 12 m.Freedom from tlr was 82% at 12m.In the cli subgroup, primary patency rate at 6 m, 12 m, and 24 m was 74%, 63%, and 33% respectively, and afs was 77% at 12 m.Over the follow-up period 63% of wounds improved or resolved post treatment.Mortality rate was 8%, 15%, and 22% at 12 m, 24 m, and 36 m, respectively.

• Brand Name: IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER
• Type of Device: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• 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: 9494452
• MDR Text Key: 177174940
• Report Number: 9612164-2019-05245
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• 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: 12/16/2019
• 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): Required Intervention