MAUDE Adverse Event Report: INVATEC SPA ADMIRAL XTREME; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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

Patient Problems Occlusion (1984); Thrombus (2101)

Event Date 10/02/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During the index procedure the anastomosis of the right arm received pre-dilation from an unknown mdt balloon and was treated with another unknown mdt balloon.It was reported that 2 months post index shunt occlusion occurred.This was treated with medication and a pta was used to treat the anastomosis.The patient received surgical intervention.The event is reported as resolved.The investigator assessed the event as not related to the index device, procedure or paclitaxel.

Manufacturer Narrative

The patient was treated with an admiral xtreme balloon catheter during the index procedure.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Cec adjudicated that event is not related to the procedure or therapy but related to the device.Revascularization is clinically driven.Cec reported that there was thrombus at the anastomosis.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Sponsor assessed that the event as not related to the index device, procedure or paclitaxel.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): INVATEC SPA; via martiri della liberta, 7; roncadelle 25030 ; IT 25030
• Manufacturer (Section G): INVATEC SPA; via martiri della liberta, 7; roncadelle 25030 ; IT 25030
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6999758
• MDR Text Key: 90983405
• Report Number: 3004066202-2017-00106
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup,Followup,Followup
• Report Date: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• 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: 08/09/2018
• 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: 85 YR