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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC COVIDIEN PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER

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MEDTRONIC COVIDIEN PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Intracranial Hemorrhage (1891); Neurological Deficit/Dysfunction (1982); Thrombosis (2100); Therapeutic Response, Decreased (2271)
Event Date 02/20/2017
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The device will not be returned for evaluation as it was implanted in the patient. Based on the reported information, there did not appear to have been any defect of the device during use. The event occurred in the patient post procedure and its cause was unknown. Citation: nimer adeeb, christoph j. Griessenauer, et al. "use of platelet function testing before pipeline embolization device placement a multicenter cohort study" accepted february 20, 2017. Stroke. 2017;48:1322-1330. Doi: 10. 1161/strokeaha. 116. 015308. Mdrs related to this report: 2029214-2017-00696, 2029214-2017-00697. 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 received information through review of literature that thromboembolic complications were encountered in 9. 2% of procedures and were symptomatic in 5. 6%. Clopidogrel nonresponders experienced a significantly higher rate of thromboembolic complications compared with clopidogrel responders (17. 4% versus 5. 6%). At a median angiographic follow-up of 13. 2 months (mean, 19. 1 months), complete occlusion was achieved in 79. 8% of aneurysms. Retreatment was performed in 5. 6% of aneurysms. The mrs score, were 0¿2 368 (93. 6) 3¿5 18 (4. 6) 6 (death) 7 (1. 8). Last follow-up modified rankin scale score improved in 32. 3% and worsened in 10. 2%; this includes patients presenting with aneurysmal subarachnoid hemorrhage. Thromboembolic complications were encountered in 9. 2% of procedures and were symptomatic in 5. 6%. Hemorrhagic complications were encountered in 3. 4% of procedures and were symptomatic in 1. 9%.
 
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Brand NamePIPELINE
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MEDTRONIC COVIDIEN
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MEDTRONIC COVIDIEN
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
9498373700
MDR Report Key6586742
MDR Text Key106973543
Report Number2029214-2017-00696
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received04/25/2017
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

Patient Treatment Data
Date Received: 05/23/2017 Patient Sequence Number: 1
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