MAUDE Adverse Event Report: MEDTRONIC MEXICO ADMIRAL XTREME OTW CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number SBI060040080

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

Patient Problems Occlusion (1984); Thrombus (2101)

Event Date 06/08/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During index procedure an admiral xtreme balloon catheter was used to treat the left anastomsis. Approximately 33 weeks post index procedure patient suffered shunt occlusion (avg to vein) to target vessel. A revasc was performed on the same date using a non medtronic device. The investigator has assessed event is not related to device, procedure or paclitaxel. The patient has recovered.

Manufacturer Narrative

The patient is a previous smoker with a medical history of hypertension, hyperlipidemia, renal insufficiency, coronary heart disease and previous revascularization of the left venous outflow. The event occurred on the (b)(6) 2018. The patient was treated with reconstruction grafting of the anastomosis. Safety assessed the event as not related to device, procedure or paclitaxel. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The patient was also treated with medication. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: it was stated that the vein near the avg was filled with thrombus. If information is provided in the future, a supplemental report will be issued.

• Brand Name: ADMIRAL XTREME OTW
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah # 10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 7662283
• MDR Text Key: 113158891
• Report Number: 9612164-2018-01618
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K062809
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 06/30/2020
• Device Catalogue Number: SBI060040080
• Device Lot Number: 213690261
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 07/04/2018 Patient Sequence Number: 1