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U.S. Department of Health and Human Services

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

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MEDTRONIC COVIDIEN PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-400-25
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Edema (1820); Hemorrhage, Subarachnoid (1893); Neurological Deficit/Dysfunction (1982)
Event Date 03/30/2016
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 cause of the hemorrhage and mass effect cannot be reliably determined. However, intracranial hemorrhage, mass effect and neurological deficits are a known inherent risk of endovascular procedure and is documented in the pipeline flex instruction for use.
 
Event Description
Medtronic received information that this patient's mass effect worsened, approximately 5 weeks post pipeline treatment. It was further reported that this patient developed a subarachnoid hemorrhage (sah) within the pipeline treatment area approximately 5 months post procedure, but the patient was confirmed to have recovered the same day. In addition, visual nerve indication post procedure was noted to have also worsened. The patient received a change in medication. It was further noted that the physician did not believe the sah and mass effect were associated with the procedure nor with the use of the pipeline. Aneurysm treated was located in the paraclinoid segment of the left internal carotid artery. The aneurysm was unruptured, fusiform, size: max diameter 17. 0 mm, neck width not measured.
 
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Brand NamePIPELINE FLEX
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 Key6483711
MDR Text Key106867261
Report Number2029214-2017-00439
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeJA
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 03/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/27/2018
Device Model NumberPED-400-25
Device Lot NumberA153763
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 Received03/17/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/28/2015
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: 04/11/2017 Patient Sequence Number: 1
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