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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN, IRVINE PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER

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COVIDIEN, IRVINE PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-375-18
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Intimal Dissection (1333); Paresis (1998)
Event Date 09/02/2017
Event Type  Injury  
Manufacturer Narrative
Device evaluation: the pipeline flex was returned for evaluation. Based on analysis, no evidence was found to suggest that the pipeline flex failed to meet specifications. All products are 100% inspected for damage and irregularities during manufacture. The event occurred in the patient post-procedure and its cause could not be conclusively determined from the reported information. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The reported device has not been received. The product was not evaluated, therefore the reported event could not be confirmed. The cause of the event could not be conclusively determined from the available information. Should the device be received for evaluation, new information shall be submitted in a follow up report. Pipeline flex embolization device instruction for use cautioned: " if high forces or excessive friction is encountered during delivery, discontinue delivery of the device and identify the cause of the resistance, remove device and micro catheter simultaneously. Advancement of the pipeline¿ flex embolization device against resistance may result in damage or patient injury. " linked mdr's 2029214-2017-01200, 2029214-2017-01201, 2029214-2017-01202, 2029214-2017-01203. 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 that a patient had right internal carotid artery dissection and hemiparesis associated with an aneurysm embolization procedure. A pipeline flex device was used with a microcatheter for the treatment of the patient's saccular aneurysm located at the right internal carotid artery at ophthalmic segment. The aneurysm measured 6mm in max diameter and 4. 10mm in neck diameter and the distal and proximal landing zone artery sizes were 3. 4mm and 3. 7mm respectively. Vessel tortuosity was described as normal. It was reported the devices were prepared following the ifu. When the pipeline flex was advanced via the microcatheter, severe resistance was met. It was further reported force was applied during delivery of the pipeline devices the pipeline device was locked up at the distal segment of the microcatheter. The devices were removed from the patient.
 
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Brand NamePIPELINE FLEX
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 Key6992279
MDR Text Key255864225
Report Number2029214-2017-01202
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeBR
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,Followup
Report Date 10/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/24/2020
Device Model NumberPED-375-18
Device Lot NumberA466071
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/07/2018
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? Yes
Date Device Manufactured05/25/2017
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: 10/31/2017 Patient Sequence Number: 1
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