MAUDE Adverse Event Report: COVIDIEN NANOCROSS ELITE CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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

Patient Problems Arrhythmia (1721); Pseudoaneurysm (2605)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Medtronic conducted a post market clinical follow-up (pmcf) survey to seek out potential new risks and assess the performance of medtronic¿s nanocross and rapidcross pta balloons. Survey results received for an interventional radiologist with 21 years¿ experience who has been using both the nanocross pta balloon and rapidcross pta balloon since 2019. The physician has used a total of 375 nanocross balloons, with all of these being used in the past 12 months for dilatation of stenoses in the iliac arteries, femoral arteries, ilio-femoral arteries, popliteal arteries, infra-popliteal arteries, and renal arteries. The nanocross pta was also used for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae and for stent post-dilation in the peripheral vasculature. The respondent reports device related complications of arrhythemia (associated with vascular spasms and pseudoaneurysm (within the stochastic norm, no outside spaces) which were not previously reported to medtronic. The events were considered to be somewhat concerning.

• Brand Name: NANOCROSS ELITE
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 9450615
• MDR Text Key: 171612840
• Report Number: 2183870-2019-00576
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (Y/N): N
• Reporter Country Code: GM
• PMA/PMN Number: K132777
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,FOREIG

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/11/2019

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 12/11/2019
• 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

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/04/2019
• 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