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

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

Patient Problem Occlusion (1984)

Event Date 10/01/2016

Event Type  Injury  

Event Description

Approximately 15 months post index procedure, the patient underwent a target vessel revascularization of the left popliteal.Two admiral xtreme and two in.Pact admiral balloons were used as treatment.Approximately 21.5 months post the revascularization of the left popliteal, the patient suffered occlusion.Patient was treated with pta, stenting and ballooning.Event is unresolved.

Manufacturer Narrative

Patient suffered restenosis and reocclusion on (b)(6) 2016 and not (b)(6) as previously reported.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information received reported that the event is resolved.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The investigator assessed this event as not related to the index device, procedure or paclitaxel.Cec adjudicated that event is related to study device, but not related to 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: 6342739
• MDR Text Key: 67801071
• Report Number: 3004066202-2017-00023
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: SI
• 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,Followup
• Report Date: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 02/13/2017
• Initial Date FDA Received: 02/20/2017
• Supplement Dates Manufacturer Received: 08/23/2017; 08/23/2017; 12/18/2017; 02/05/2018
• Supplement Dates FDA Received: 09/04/2017; 09/06/2017; 01/02/2018; 02/13/2018
• 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: 61 YR
• Patient Weight: 100