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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER

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MEDTRONIC PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number NV UNK FLEX
Device Problem No Apparent Adverse Event (3189)
Patient Problems Intracranial Hemorrhage (1891); Cognitive Changes (2551)
Event Date 05/01/2015
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Oguz s, tabakci ön, uysal e, bulut e, dinç h. Pipeline flex embolization device (ped flex) for the treatment of intracranial aneurysms: periprocedural outcomes and first-year angiographic results.  turkish journal of medical sciences. 2019;49(6):1640. Http://search. Ebscohost. Com/login. Aspx?direct
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eds-live. Accessed march 16, 2020. Medtronic received a report regarding a study to evaluate the efficacy of the pipeline flex device. The authors reviewed 49 patients with a mean age of 52 years, 63% female. The average aneurysm diameter was 8mm. Intraprocedural or periprocedural thromboembolic events occurred in four patients. All these presented with minor neurological deficits, and there were no clinical deficits at discharge.
 
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Brand NamePIPELINE FLEX EMBOLIZATION DEVICE
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MEDTRONIC
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MEDTRONIC
9775 toledo way
irvine CA 92618
Manufacturer Contact
katcha taylor
9775 toledo way
irvine, CA 92618
9496801345
MDR Report Key9836772
MDR Text Key190148199
Report Number2029214-2020-00234
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeTU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 03/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNV UNK FLEX
Device Catalogue NumberNV UNK FLEX
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/05/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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