MAUDE Adverse Event Report: MEDTRONIC MEXICO PACIFIC XTREME; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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

Patient Problems Embolism (1829); Hematoma (1884); Reocclusion (1985); Perforation (2001); Thrombus (2101); Patient Problem/Medical Problem (2688); Vascular Dissection (3160)

Event Date 07/18/2018

Event Type  Injury  

Manufacturer Narrative

Age: average age.Gender: majority gender.Event date: date of article publication."transradial versus tibiopedal access approach for endovascular intervention of superficial femoral artery chronic total occlusion." catheter cardiovasc interv.2018; 92: 1338¿1344.Doi: 10.1002/ccd.27689.If information is provided in the future, a supplemental report will be issued.

Event Description

Background: improved equipment and techniques have resulted in transition from surgical bypass to endovascular intervention to treat superficial femoral artery (sfa) chronic total occlusions (cto).A change in access site to radial (tra) or tibiopedal (tpa) artery for the treatment of these sfa cto has been reported.The feasibility, efficacy and safety of these two access sites for treatment of sfa cto have not been reported.Event description: 161 patients were treated (1/2014) to (9/2016), for cto in the superficial femoral artery.The patients were treated with a pacific xtreme balloon, pacific plus balloon, inpact admiral dcb balloon, inpact pacific dcb balloon, everflex entrust se stent, complete se stent, chocolate balloon and non-medtronic devices.The patients have a history of pad, cad, hypertension, hyperlipidemia, tobacco use and diabetes.It was reported the physician was unable to cross the lesion, patients presented with 3 flow limiting dissections treated with stenting, arterial perforations, bleeding hematomas, distal embolization, tvr, 1 thrombus formation in the popliteal artery, treated with stenting, 1 limb amputation, cerebrovascular accident and 2 deaths.Methods: we performed an as treated analysis of 184 sfa cto interventions in 161 patients from 01/2014 to 09/2016 using either primary tra or tpa (operator discretion) at two institutions.Primary end point was 30 day major adverse event (mae) - death, amputation or target vessel revascularization, secondary endpoint was success of procedure.Results: primary tra was used in 46 patients with 47 cto lesions.Primary tpa was used in 115 patients with 137 cto lesions.Primary crossing success rate was higher with tra compared to tpa (74% vs 54%, p50.01).Dual tra-tpa was required in 72 prior uncrossed lesions resulting in a crossing and procedural success of 99% and 96% respectively.The overall crossing and procedural success rate using either of these approaches was 99% and 98% respectively.The 30 day mae was 5% in tra arm, 0% in tpa arm and 2% in dual tra-tpa arm, p50.08.All access sites were patent, confirmed by ultrasound.Conclusion: the treatment of sfa cto is feasible and safe using both tra or tpa approach providing high success rates and no access site complications.Devices reported in the article are inpact admiral, pacific xtreme, pacific plus, chocolate, complete se, everflex entrust.

• Brand Name: PACIFIC XTREME
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): MEDTRONIC MEXICO; avenida paseo del cucapah #105; parque industrial el lago; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; avenida paseo del cucapah #105; parque industrial el lago; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8666397
• MDR Text Key: 146920122
• Report Number: 9612164-2019-02148
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103464
• 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: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2019
• 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: 05/13/2019
• 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
• Patient Age: 72 YR