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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Therapeutic Response, Decreased (2271)
Event Date 05/10/2017
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The device was no returned for analysis as the device was implanted. There are various mechanisms underlying late aneurysm recanalization which including the following: growth of the aneurysm itself, instability of fresh, unorganized thrombus and degradation by fibrolysis, continued transmission of blood pulsation affecting the association of the coil-thrombus complex, lack of neointima formation across the neck of aneurysm, formation of neovessels inside the aneurysms lumen, exposing the aneurysm cavity to blood flow. In this case, it is unknown what caused the endo leak. A meta-analysis by murthy et al (2014) showed that 6 months aneurysm occlusion rate after endovascular treatment of intracranial aneurysm with flow diverter is 79. 7%. In this event, the patient was treated successfully treated with another device. Linked event: 2029214-2017-00735, 2029214-2017-00737 and 2029214-2017-00738.
 
Event Description
Medtronic received report that 2 years post initial treatment with single flow diverter device (4. 25 x 16), there was still filling of the left ica aneurysm, which was not in a bend. An additional device was added to close a distal edge endo leak. The aneurysm was saccular and unruptured with a 10 mm max and 7 mm neck, within the left ica/periophthalmic and was 10 mm. The landing zone was 4. 5 at the distal section and 3. 75 at the proximal. It is unknown where the resistance was coming from, as the anatomy appeared straightforward.
 
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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 Key6615835
MDR Text Key106975296
Report Number2029214-2017-00736
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2017
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 Received05/10/2017
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: 06/06/2017 Patient Sequence Number: 1
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