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U.S. Department of Health and Human Services

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

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COVIDIEN (IRVINE) PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number FA-77350-12
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Infarction, Cerebral (1771); Neurological Deficit/Dysfunction (1982); Thrombosis (2100)
Event Date 06/01/2017
Event Type  Injury  
Manufacturer Narrative
Dornbos, d. , and powers, c. J. (2017). Acute distal migration of a flow diverting stent. Journal of clinical neuroscience. Doi:1 0. 1016/j. Jocn. 2017. 05. 009. The pipeline device remains implanted in the patient; product analysis cannot be performed. The reported event could not be confirmed. An event cause could not be conclusively determined from the provided information. 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
Medtronic literature review found a report of pipeline migration after implantation as well as cerebral infarction. The patient underwent pipeline implantation in the treatment of a left paraclinoid aneurysm. Intra-operatively, the patient was found to have a 4. 1 x 5. 0 x 4. 8 mm aneurysm in the vicinity of the superior hypophyseal artery. A 3. 5 x 12 mm pipeline device was placed without complication under therapeutic heparinization. Immediate post-placement angiography revealed stagnation within the aneurysm dome with no evidence of impaired flow. Upon emergence from general anesthesia, the patient was initially moving all extremities symmetrically. While still on the operative table, the patient developed acute right hemiparesis and a right facial droop. Angiography was emergently repeated, which revealed complete thrombosis of the stent and proximal mca. The pipeline was noted to have migrated to the supraclinoid ica, after which the patient received intra-arterial tissue plasminogen activator and attempted thrombus aspiration. The patient was maintained on abciximab overnight. The article states that despite tici 2b revascularization, the patient experienced a dominant left mca infarct.
 
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Brand NamePIPELINE EMBOLIZATION DEVICE
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
9496801224
MDR Report Key6699588
MDR Text Key79574077
Report Number2029214-2017-00871
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S004
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 06/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFA-77350-12
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 Received06/12/2017
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

Patient Treatment Data
Date Received: 07/10/2017 Patient Sequence Number: 1
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