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

Model Number AB35W05120135

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

Patient Problem Death (1802)

Event Date 09/22/2014

Event Type  Death  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

On (b)(6) 2014, the subject underwent the index procedure on a 180mm, 90% stenotic de-novo lesion of the left mid-sfa.The subject was randomized to the bare balloon.The lesion was pre-dilated with an unknown 4x50 pta balloon resulting in a residual stenosis of 30%.The 5x120 evercross pta balloon was inserted and inflated to 10 atm for 5 minutes resulting in 0% residual stenosis.Following that, another 5x080 evercross pta balloon was inserted and inflated to 10 atm for 10 minutes resulting in 0% stenosis.The subject was discharged on (b)(6) 2014 with no complications.Third evercross balloon, 5x40 was not inflated.Unknown reason.On (b)(6) 2017, the clinical site became aware that the subject had died on (b)(6) 2017.No additional information is available at this time.

• Brand Name: EVERCROSS 035
• 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: 6853623
• MDR Text Key: 85465372
• Report Number: 2183870-2017-00387
• 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: health professional,study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/07/2016
• Device Model Number: AB35W05120135
• Device Catalogue Number: AB35W05120135
• Device Lot Number: 9785854
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/11/2017
• Date Device Manufactured: 08/08/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 88 YR