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U.S. Department of Health and Human Services

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

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COVIDIEN (IRVINE) PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-500-25
Device Problems Material Twisted/Bent (2981); Activation Failure (3270)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 07/12/2018
Event Type  Malfunction  
Manufacturer Narrative

The device has been received, however, the device analysis has yet not began. A supplemental report will be submitted. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Medtronic received report that during delivery of the pipeline it twisted. A triaxial system to achieve utmost support was not used when introducing the pipeline. The distal end opened perfectly but as we left a straight segment for a curve proximally, the pipeline would twist. After a couple resheathing and wagging opportunities, the physician thought it was best to remove system. A new device was used to treat the patient. The aneurysm was in the right internal carotid artery (ica) pcom. It was unruptured, fusiform, with a max diameter of 5mm and neck of 5mm. The distal landing zone was 10mm and proximal was 5mm. The anatomy was moderate in tortuosity.

 
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Brand NamePIPELINE FLEX
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
gabriela mclellan
9775 toledo way
irvine, CA 92618
9492753836
MDR Report Key7757851
MDR Text Key116860888
Report Number2029214-2018-00699
Device Sequence Number1
Product Code OUT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/02/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/07/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/26/2020
Device MODEL NumberPED-500-25
Device LOT NumberA482850
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/13/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated By Manufacturer? No
Date Device Manufactured06/27/2017
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: 08/07/2018 Patient Sequence Number: 1
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