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

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

Patient Problem Hemorrhage/Bleeding (1888)

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 vascular surgeon with 14 years¿ experience who was been using the nanocross pta balloons since 2016.The physician has used a total of 15 nanocross balloons, with 11 of these being used in the past 12 months for dilatation of stenoses in the femoral arteries, ilio-femoral arteries, popliteal arteries, infra-popliteal arteries, renal arteries as well as for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula.The nanocross device was also used for stent post-dilatation in the peripheral vasculature.A haemorrhage event is reported as a device related complication during treatment of a fragile vessel where on cannulation submucosal entry made a subintimal bleed.This event was reported 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: 9450408
• MDR Text Key: 170931805
• Report Number: 2183870-2019-00574
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K132777
• 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
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was 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
• Date Manufacturer Received: 12/04/2019
• 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