MAUDE Adverse Event Report: MEDTRONIC COVIDIEN UNKNOWN NAVIEN INTRACRANIAL SUPPORT CATH; CATHETER, PERCUTANEOUS

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

Patient Problem Vasoconstriction (2126)

Event Date 10/29/2015

Event Type  Injury  

Manufacturer Narrative

The device model and lot numbers were not reported.The device was not returned; therefore, no definitive conclusion can be drawn regarding the clinical observation.However, based on the reported information, there is no evidence suggesting that the device was defective, but rather a procedure related event.Vessel spasm is a known inherent risk of endovascular procedure and is documented in the navien instruction for use.

Event Description

Medtronic received information that a patient experienced a mild catheter induced vasospasm while undergoing a flow diversion treatment for an aneurysm located in the clinoid segment of the left internal carotid artery.The vasospasm resolved immediately upon the administration of verapamil.The patient was discharged asymptomatic.

• Brand Name: UNKNOWN NAVIEN INTRACRANIAL SUPPORT CATH
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MEDTRONIC COVIDIEN; 9775 toledo way; irvine 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine 92618 ; 9498373700
• MDR Report Key: 5302174
• MDR Text Key: 33630352
• Report Number: 2029214-2015-05207
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2015
• 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: 00054 YR