MAUDE Adverse Event Report: INVATEC TECHNOLOGY CENTER GMBH ADMIRAL XTREME PTA BALLOON CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Device Problems Occlusion Within Device (1423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Ischemia (1942)

Event Date 12/24/2014

Event Type  Injury  

Event Description

During the index procedure, the physician used three in.Pact admiral paclitaxel-eluting pta balloon catheters to treat a lesion located in the sfa of the right leg.Six months later, the right sfa was treated with 2 admiral xtreme pta balloon catheters and 1 pacific plus pta balloon catheter.It was reported that 20 months post index procedure, the patient experienced occlusion of the right femoral-popliteal bypass with acute ischemia of the right leg.Pta was carried out as treatment.Investigator has assessed the event as not related to the study device or procedure.Outcome of event reported as continuing.

Manufacturer Narrative

Evaluation results: inherent risk of procedure ¿ (occlusion).Evaluation conclusions: inherent risk of procedure ¿ (occlusion).(b)(4).

Event Description

Additional information: investigator has assessed the previously reported occlusion of the right femoral-popliteal bypass as not related to the paclitaxel.The patient is reported to have recovered.

Event Description

The previously reported occlusion which occurred approximately 20 months post index procedure was of the right femoral-tibial bypass.

• Brand Name: ADMIRAL XTREME PTA BALLOON CATHETER
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): INVATEC TECHNOLOGY CENTER GMBH; hungerbuelstrasse 12; frauenfeld 8500 ; CH 8500
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 4490029
• MDR Text Key: 21450778
• Report Number: 3004066202-2015-00039
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K062809
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2015
• 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: 03/12/2015
• 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: 00058 YR
• Patient Weight: 92