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

Catalog Number AB35W07040135

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

Patient Problem Stenosis (2263)

Event Date 12/14/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During index procedure, a medtronic standard pta was used to treat the left venous outflow.Approximately 12 months post procedure, patient suffered restenosis of the proximal cephalic vein outflow and the venous outflow was treated with a medtronic standard pta balloon same day.The patient recovered.The investigator and sponsor assessed the event as not related to the device, procedure or paclitaxel.

Manufacturer Narrative

A stent was also implanted during index procedure to treat persistent residual stenosis.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the devices used during the index procedure were an evercross balloon and an everflex stent.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 IRELAND; parkmore business park west; galway 22570
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8849692
• MDR Text Key: 152895396
• Report Number: 9612164-2019-03165
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173515
• 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,Followup
• Report Date: 10/22/2019

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
• 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
• Initial Date Manufacturer Received: 07/16/2019
• Initial Date FDA Received: 08/01/2019
• Supplement Dates Manufacturer Received: 07/16/2019; 09/25/2019
• Supplement Dates FDA Received: 08/01/2019; 10/22/2019
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR