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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-400-16
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Intracranial Hemorrhage (1891); Neurological Deficit/Dysfunction (1982)
Event Date 09/18/2018
Event Type  Injury  
Manufacturer Narrative
The pipeline flow device was not returned as it was implanted in the patient; therefore, product analysis of the flow device was not able to be performed.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.Based on the reported information, there was no reasonably suggestion that a malfunction or quality deficiency of the pipeline device occurred during the treatment procedure or during the second procedure.There is no evidence suggesting that the devices were defective, but rather a patient condition and post procedure related event, as the patient¿s pru level was slight high (reported to be around 180).It is possible that the hemodynamic changes induced by the flow diverter may have contributed to the reported post procedure events of headache and aneurysm rupture.Delayed aneurysm rupture after flow diversion occurs in approximately 1% of patients, and its mechanism may involve sudden hemodynamic changes in intra-aneurysmal flow pattern or aneurysm wall weakening due to inflammation and proteolytic enzymes within the developing red thrombus.However, the exact cause remains unknown.Headaches and aneurysm rupture are known inherent risks of endovascular procedure and are documented in our device¿s instruction for use (ifu).If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received report that seven days post the uneventful pipeline embolization procedure, the aneurysm ruptured.The patient presented to the emergency department with a severe headache and high blood pressure.The patient was initially treated for a unruptured internal carotid artery in paraophthalmic.The max diameter was 20mm.The pru level was around 180 and the p2y12 was 4.The anatomy was minimal in tortuosity.The patient did require additional medical intervention, which consisted of a drain being placed and 2 additional flow divertors, this was performed 12 days after the initial placement.The patient was reported to still be hospitalized.
 
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Brand Name
PIPELINE FLEX
Type of Device
INTRACRANIAL 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 Key7940667
MDR Text Key123045855
Report Number2029214-2018-00834
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 10/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date04/29/2019
Device Model NumberPED-400-16
Device Lot NumberA270150
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/18/2018
Initial Date FDA Received10/05/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/29/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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