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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN (IRVINE) PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER

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COVIDIEN (IRVINE) PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number FA-77475-18
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Injury (2348)
Event Date 02/09/2015
Event Type  Injury  
Manufacturer Narrative

(b)(4). The device was not returned for evaluation as it was implanted. Vasospasm is a known inherent risk of pipeline procedure and is documented in the pipeline flex instruction for use. Based on the reported information, there is no evidence suggesting that device was defective, but rather a procedure related event.

 
Event Description

Medtronic received information that a patient experienced vasospasm during pipeline procedure. The patient was treated for a small unruptured right paraopthamic internal carotid artery (ica) aneurysm. The pipeline embolization was deployed and there was stasis of contrast noted within the aneurysm, as expected. The flow through the opthalmic artery was noted to be slow and there was evidence of vasospasm involving the distal ica, so 30 mg of intra-arterial verapamil was administered and a balloon was used to perform angioplasty within the ped. This resulted in good wall apposition and opening of the stent throughout and improved flow within the right opthalmic artery. There were no local or distal thromboembolic complications demonstrated on the conclusion angiography. The patient awoke with no new neurological deficits. The patient was commenced on a therapeutic heparin infusion to avoid complications with flow through the opthalmic artery. No patient injury was reported as a result of this procedure.

 
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Brand NamePIPELINE
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
COVIDIEN (IRVINE)
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
COVIDIEN (IRVINE)
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
9498373700
MDR Report Key5163763
MDR Text Key28838352
Report Number2029214-2015-05059
Device Sequence Number1
Product Code OUT
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberP100018.S004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 09/24/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/21/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/08/2016
Device MODEL NumberFA-77475-18
Device LOT Number9777443
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured07/22/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/21/2015 Patient Sequence Number: 1
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