MAUDE Adverse Event Report: MEDTRONIC EVERCROSS 035; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number AB35W07040135

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

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 12/01/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During the index procedure, a medtronic standard pta was being used to treat the venous outflow.After repeat balloon angioplasty, venous elastic recoil of the left cephalic vein occurred leading to a placement of a 7x40mm self expanding stent in the cephalic vein outflow tract.The patient recovered.The investigator assessed the event as not related to the index device, procedure or paclitaxel medication.Safety assessed the event as not related to the device or paclitaxel but related to the procedure.

Manufacturer Narrative

It was reported that an evercross standard pta was used during index procedure and not admiral extreme as previously reported.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EVERCROSS 035
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): MEDTRONIC; 4600 nathan lane; plymouth MN 55442
• Manufacturer (Section G): MEDTRONIC; 4600 nathan lane; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8031842
• MDR Text Key: 125902452
• Report Number: 9612164-2018-03032
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/06/2020
• Device Catalogue Number: AB35W07040135
• Device Lot Number: A552368
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2018
• 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: 79 YR