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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN (IRVINE) PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER

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COVIDIEN (IRVINE) PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-400-14
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hemorrhage, Cerebral (1889)
Event Date 02/22/2016
Event Type  Death  
Manufacturer Narrative
(b)(4). The pipeline flex 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. Intracerebral bleeding is a known inherent risk of flow diversion procedure and is documented in the pipeline flex instruction for use. Daou, et al (2015), in their article "p2y12 reaction units: effect on hemorrhagic and thromboembolic complications in patients with cerebral aneurysms treated with the pipeline embolization device" reported that pru level less than 60 carry higher odds of hemorrhagic complications. In this patient, the pru level was reported to be 44 at the time of the intracerebral hemorrhage. The cause of the ich cannot be definitively determined; however, per the reported information, review of ifu, and review of literature to investigate the event, the most likely cause of the ich is clopidogrel hyper-response.
 
Event Description
Medtronic received report that a patient experienced an intracerebral hemorrhage (ich) after pipeline flex implantation. The patient received the pipeline flex implant to treat an unruptured, saccular aneurysm in the left paraophthalmic internal carotid artery (ica). The aneurysm measured 12x12x3mm. Parent artery was 5mm. The patient's vessel was moderately tortuous. The patient also had a previously coiled aneurysm in the posterior communicating artery. The pipeline flex was implanted and no device issues were reported during the procedure. Post-procedure angiographic result showed semi-sphere of stagnant contrast in aneurysm, which was expected. Four days post-procedure, the patient reportedly experienced an ich in the left parietal/temporal region and left middle cerebral artery (mca). The bleed was reportedly not due to the aneurysm and there was no subarachnoid hemorrhage (sah). The patient had a living will, so no intervention was performed. The patient passed away one day after the ich.
 
Manufacturer Narrative
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.
 
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Brand NamePIPELINE FLEX EMBOLIZATION DEVICE
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
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
9496801224
MDR Report Key5521242
MDR Text Key41006494
Report Number2029214-2016-00159
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
Type of Report Initial,Followup
Report Date 02/26/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/05/2018
Device Model NumberPED-400-14
Device Lot NumberA054201
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 Received02/26/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/06/2015
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: 03/23/2016 Patient Sequence Number: 1
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