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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 Problems Difficult to Open or Close (2921); Material Deformation (2976); Activation Failure (3270); Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/05/2018
Event Type  malfunction  
Manufacturer Narrative
The device was not returned for analysis as it was implanted. The investigation is under way. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received report that during the embolization procedure, the middle section of the pipeline stent could not be opened the at the vascular transition. The ped was attempted to be retrieved, but there was resistance to recovery the stent. After complete recovery of the pipeline, the pipeline and microcatheter were completely withdrawn from the body. Upon assessment of the microcatheter, it was found to have slight wrinkle-like deformation at the distal end, a new microcatheter was selected, and the pipeline stent was introduced to complete the operation. A continuous flush was maintained during the procedure. The devices were all used per their ifu. The anatomy was normal. With the support of 5f artery sheath expansion core, the ped was pushed from the original microcatheter tip and directly loading it into the new microcatheter hub, and then pushed into microcatheter. From images provided it appears the distal landing zone was 2. 89mm, proximal was 4. 09mm.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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
gabriela mclellan
9775 toledo way
irvine, CA 92618
9492753836
MDR Report Key7735371
MDR Text Key116049265
Report Number2029214-2018-00685
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/31/2018
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 Received08/08/2018
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

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