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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-475-25
Device Problem Activation Failure (3270)
Patient Problem Fistula (1862)
Event Date 10/23/2018
Event Type  Injury  
Manufacturer Narrative
The pipeline flex was not returned for analysis; therefore, no definitive conclusion can be drawn regarding the clinical observation. However, the device is pending return. Upon receipt of the device a supplemental report will be filed. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that during treatment of cerebral aneurysm with a medtronic flow diversion device, it did not open at the proximal end. The physician stated that the internal carotid-cave 15 mm blood vessel distal to the aneurysm was tortuous. Prior to the reported event, the medtronic guide catheter was advanced until it could go no further (distal of the aneurysm), and then they started to deploy the flow diversion device. The medtronic flow diversion device opened up several mm from the tip of the flow diversion device, but it did not open at the proximal end despite several attempts at deploying it. As the physician decided to discontinue the attempts, the patient complained about pain. Also, during the angiography with contrast, a carotid cavernous fistula (ccf) was found, so they stopped using the reported product. The vessel was severely tortuous. The procedure was not completed. After that procedure, coiling therapy was carried out with tve, but the condition did not recover, and an operation was performed the other day. It was reported that the patient¿s condition was stable.
 
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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
9498373700
MDR Report Key8061873
MDR Text Key126922482
Report Number2029214-2018-00935
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 02/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/11/2021
Device Model NumberPED-475-25
Device Lot NumberA628385
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/20/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/24/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/12/2018
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: 11/12/2018 Patient Sequence Number: 1
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