MAUDE Adverse Event Report: COVIDIEN (IRVINE) UNKNOWN DIRECTIONAL ATHERECTOMY; CATHETER, PERIPHERAL, ATHERECTOMY

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

Patient Problem Embolism (1829)

Event Date 04/27/2016

Event Type  Injury  

Event Description

A review article was published to study the applications and techniques of peripheral atherectomy devices.A retrospective review of medtronic¿s directional atherectomy devices to treat in-stent restenosis involved the use of distal embolic protection (dep) device, spider fx in 56% of cases.It was reported in the article that distal embolization requiring treatment occurred in 7% of patients, and debris was present in the dep in 82% of them.It was reported that if the operator exerts too great a force on the wire to pull the basket into the retrieval catheter, it is possible to extrude material through the interstices of the filter resulting in distal embolization.

Manufacturer Narrative

Title of article: peripheral atherectomy: application and techniques tech vasc interventional rad 16:123-135 http://dx.Doi.Org/10.1053/j.Tvir.2016.04.005.

• Brand Name: UNKNOWN DIRECTIONAL ATHERECTOMY
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6640100
• MDR Text Key: 77537558
• Report Number: 2183870-2017-00255
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071432
• 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: 05/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2017
• 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: 05/15/2017
• 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