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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Therapeutic Response, Decreased (2271); Thromboembolism (2654)
Event Date 02/24/2017
Event Type  Injury  
Manufacturer Narrative
The pipeline devices will not be returned for evaluation as they remain implanted in the patients. Based on the information provided in the article, there did not appear to have been any defect of the devices during use. The events occurred in the patients post-procedure and its causes could not be conclusively determined from the information provided in the article. Griessenauer cj, shallwani h, adeeb n, gupta r, rangel-castilla l, siddiqui ah, levy ei, boone md, thomas aj, ogilvy cs, conscious sedation versus general anesthesia for the treatment of cerebral aneurysms with flow diversion: a matched cohort study, world neurosurgery (2017), doi: 10. 1016/j. Wneu. 2017. 02. 111. 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 reports of patient complications after pipeline implantation. The purpose of this article was to compare flow diverter placement performed under conscious sedation to general anesthesia in a matched cohort study. The authors retrospectively reviewed 70 patients (67/70 received pipeline) who underwent flow diverter placement under conscious sedation and 70 patients (69/70 received pipeline) under general anesthesia. In both groups, 60 patients were female, 10 were male; median age was 60 years. The article states that the following outcomes occurred in patients who underwent treatment under conscious sedation: - 2 underwent endovascular retreatment - 5 worsened in mrs - 4 experienced thromboembolic complications, 3 of which were symptomatic - 4 experienced hemorrhagic complications, 1 of which was symptomatic - 7 experienced ¿other complications¿ the article states that the following outcomes occurred in patients who underwent treatment under general anesthesia: - 1 underwent endovascular retreatment - 5 worsened in mrs - 2 experienced thromboembolic complications, 1 of which was symptomatic - 1 experienced symptomatic hemorrhagic complication - 10 experienced ¿other complications¿.
 
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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 Key6540696
MDR Text Key74300241
Report Number2029214-2017-00618
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 04/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2017
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 Received04/07/2017
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: 05/03/2017 Patient Sequence Number: 1
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