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 Problems Occlusion (1984); Reocclusion (1985); Thrombus (2101); Vascular Dissection (3160)

Event Date 10/03/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Purpose: to report a post hoc analysis comparing outcomes between subjects who would have been included in the in.Pact sfa randomized controlled trial vs those who would have been excluded.Event description: 1406 subjects enrolled in the in.Pact global study, 281 patients based on the inclusion and exclusion criteria from the randomized in.Pact sfa trial; the remaining 1125 patients were assigned to the broader-use group.The in.Pact admiral dcb was used to treat intermittent claudication and/or ischemic rest pain due to atherosclerotic disease of the femoropopliteal segment, including the entire native sfa.The patients have a history of mellitus, insulin-dependent, hypertension, hyperlipidemia, current smoker, coronary heart disease, carotid artery disease, renal insufficiency, previous peripheral revascularization below-the-knee.The patients presented post procedure with isr, tvr, tlr, death cec determined deaths are not related to the device or procedure, amputation, thrombosis.Methods: the 1406 subjects enrolled in the in.Pact global study (clinicaltrials.Gov identifier (b)(4)) were retrospectively assigned to a standard-use group (n=281) based on the inclusion and exclusion criteria from the randomized in.Pact sfa trial; the remaining 1125 patients were assigned to the broader-use group.Freedom from clinically-driven target lesion revascularization (cd-tlr) was evaluated at 12 months.The composite primary safety endpoint was freedom from 30-day device- and procedure related death plus freedom from 12-month target limb major amputation and clinically-driven target vessel revascularization (cd-tvr).Functional outcomes were evaluated with dedicated questionnaires.Results: compared with the standard-use cohort, the broader-use lesions were longer, more calcified, and had more popliteal involvement, bilateral disease, and in-stent restenosis (p<(><<)>0.001 for all).Freedom from 12-month cd-tlr by kaplan-meier analysis was 96.6% for the standard use group and 91.6% for the broader-use group (p=0.005).The safety endpoint was 96.2% in the standard-use group and 91.0% in the broader-use group (p=0.003).The 12-month cd-tlr (3.4% standard-use vs 8.5% broader-use, p=0.004) and cd-tvr (4.2% standard-use vs 9.1% broader-use, p=0.008) were increased in the broader-use group.Twelve-month all-cause mortality was not increased (3.8% standard-use vs 3.4% broader-use, p=0.852).

• 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: 8216365
• MDR Text Key: 132038783
• Report Number: 9612164-2019-00040
• 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: 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 12/10/2018
• Initial Date FDA Received: 01/04/2019
• 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): Other
• Patient Age: 69 YR