MAUDE Adverse Event Report: MEDTRONIC MEXICO ADMIRAL XTREME; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

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

Patient Problems Rupture (2208); Obstruction/Occlusion (2422); Embolism/Embolus (4438); Restenosis (4576)

Event Date 11/12/2020

Event Type  Injury  

Manufacturer Narrative

Journal title: endovascular management of aorto-iliac occlusive disease (leriche syndrome) journal of the formosan medical association 120 (2021) 1485e1492 https://doi.Org/10.1016/j.Jfma.2020.10.033 a2 average age a3 majority gender b3 date of publication.If information is provided in the future, a supplemental report will be issued.

Event Description

The article received reported study of high-risk patient with chronic aorto-iliac occlusive disease were retrospectively reviewed.Medtronic's admiral xtreme pta balloon was used for dilatation and complete se was one of the bare metal stents implanted.A total of 28 iliac arteries and 14 occluded abdominal aorta were treated with 100% technical success, of which 25% success were achieved by using subintimal technique.Two minor complications occurred, including vascular rupture and distal emboli in one patient apiece, which were successfully managed via endovascular fashion.There was two reinterventions; 2 months and 24 months post procedure respectively.Two patients expired after treatment due to causes unrelated to our procedures - one at 3 weeks because of pneumonia and the other at 6 months due to underlying myelo-proliferative disorder.

• Brand Name: ADMIRAL XTREME
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12486376
• MDR Text Key: 271853666
• Report Number: 9612164-2021-03564
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K062809
• 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: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• 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: 09/07/2021
• 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: 60 YR