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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
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Stenosis (2263); Therapeutic Response, Decreased (2271)
Event Type  Injury  
Manufacturer Narrative
The device was not returned for evaluation as it was implanted in the patient. The device was not returned for analysis; therefore, the complaint of migration after deployment issue could not be confirmed, and the event cause could not be determined. It is possible that the reported mass effect of the partially thrombosed aneurysm induced parent vessel stenosis; this remodeling of the vessel caused the initial device to inadequately cover the aneurysm neck. Per our instructions for use (ifu): a thrombosed aneurysm may aggravate pre-existing, or cause new, symptoms of mass effect and may require medical therapy. Do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Citation: ¿effect of antiplatelet therapy on thromboembolism after flow diversion with the pipeline embolization device¿ robert s. Heller, m. D. , venkata dandamudi, m. D. , michael lanfranchi, m. D. , and adel m. Malek, m. D. , ph. D. Medtronic received report that 23 patients with 26 intracranial aneurysms received a ped for treatment of their aneurysms. The mean age of 55. 6 years (range 17¿77 years) and consisted of 5 men and 19 women. A single aneurysm required repeat treatment following the initial flow diverter embolization. Mass effect of the partially thrombosed aneurysm induced parent vessel stenosis; which remodel the vessel caused the initial flow diverter to inadequately cover the aneurysm neck, requiring deployment of a second device.
 
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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
9492753836
MDR Report Key6809869
MDR Text Key83220620
Report Number2029214-2017-00982
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 08/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 Received08/02/2017
Was Device Evaluated by Manufacturer? No
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: 08/22/2017 Patient Sequence Number: 1
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