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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 Problem Therapeutic Response, Decreased (2271)
Event Date 03/01/2017
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: ki-su park, dong-hun kang, won-soo son, et al. ¿a case of ruptured blood blister-like aneurysm treated with pipeline embolization device: clinical significance of fetal-type posterior communicating artery. ¿ neurointervention. 12:40-44; 2017 mdrs related to this report 2029214-2017-00553 2029214-2017-00554.
 
Event Description
Medtronic received information through review of literature that there was a case of aneurysm regrowth following pipeline embolization device (ped) application for a ruptured blood blister like aneurysms (bba). It was reported that 10 days post ped deployment, dsa revealed intraneurysm contrast filling and regrowth. Additional treatments were planned, which included balloon angioplasty with the first ped was performed to achieve complete apposition to the internal carotid artery (ica) wall. Then, an additional ped was implanted within the previous ped for stronger flow diversion. However, contrast filling into the bba still remained after the procedure. Eventually coil trapping at the original of the fetal type posterior communicating artery (pcoa) was planned. A total of non-medtronic coils were deployed and dsa showed complete occlusion of the origin of the pcoa and no contrast filling into the bba from ica. Postoperative clinical course was uneventful. The patient was discharged without any neurological deficit.
 
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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 Key6520866
MDR Text Key106989758
Report Number2029214-2017-00554
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
P100018.S004
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 03/29/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2017
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 Received03/29/2017
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: 04/25/2017 Patient Sequence Number: 1
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