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

Catalog Number UNK-CV-GWY-ADM

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

Patient Problems Aneurysm (1708); Patient Problem/Medical Problem (2688)

Event Date 05/10/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During the index procedure one medtronic standard pta device was used to treat a lesion located in the venous outflow of the left arm. Approximately 2 months post index procedure, patient suffered an aneurysm in the area of the fistula. Event was treated with a surgical intervention of the venous outflow. Investigator assessed that the event is not related to index device, procedure or antiplatelets medication. Outcome of the event is unknown.

Manufacturer Narrative

Patient has a history of hypertension, renal insufficiency, coronary heart disease and previous peripheral revascularization of the in cannulation zone and venous outflow. Event was treated with pta of venous outflow. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Ae term updated to "avf aneurysm" and patient recovered. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

It was confirmed that the index device was not a medtronic pta. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

A medtronic standard pta device was during the index procedure. If information is provided in the future, a supplemental report will be issued.

• Brand Name: ADMIRAL XTREME
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• 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: 7609375
• MDR Text Key: 111318796
• Report Number: 9612164-2018-01466
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062809
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK-CV-GWY-ADM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/16/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 06/18/2018 Patient Sequence Number: 1