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

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

Patient Problems Occlusion (1984); Stenosis (2263)

Event Date 09/08/2017

Event Type  Injury  

Event Description

During a revascularisation of the mid left sfa, the patient was treated with one pacific xtreme pta balloon catheter.During another revascularisation of the mid left sfa, the patient was treated with one amphiprion deep pta balloon catheter.Approximately one year post the first revascularisation and 9 month post the second, the patient suffered restenosis of the target lesion in the left femoral superficial artery.This was treated with a pacific xtreme pta balloon catheter on the same day.The patient recovered.

Manufacturer Narrative

The cec has adjudicated that the event is related to the device but not the procedure or paclitaxel.The investigator reported that the event is not related to the index device, procedure or paclitaxel.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The event term is updated to occlusive restenosis.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

• Brand Name: PACIFIC 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: 7062561
• MDR Text Key: 93031459
• Report Number: 3004066202-2017-00115
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: K103464
• 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: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2017
• 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: 03/12/2018
• 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: 74 YR
• Patient Weight: 70