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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-450-14
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Therapeutic Response, Decreased (2271)
Event Date 04/13/2016
Event Type  Death  
Manufacturer Narrative
Citation: italo linfante, michael mayich, ashish sonig, jena fujimoto, adnan siddiqui, guilherme dabus. Flow diversion with pipeline embolic device as treatment of subarachnoid hemorrhage secondary to blister aneurysms: dual-center experience and review of the literature. J neurointervent surg 2017 the pipeline devices were implanted in the treatment of a ruptured blister aneurysm along the dorsum of the right internal carotid artery (ica). The pipeline devices will not be returned for evaluation as they were implanted in the patient. Therefore, product analysis cannot be performed. There were no device issues noted during implantation as three pipeline were implanted without complication. The patient presented with an aneurysmal subarachnoid hemorrhage (asah) which was found as a result of a ruptured blister aneurysm. Mrs at sah was 5. According to the authors of the study, the patient died as a consequence of the original sah and subsequent severe vasospasm. Vasospasm is a known inherent risk of endovascular procedure and is documented in the pipeline instruction for use. 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 the cause of the patient death was likely related to the original sah and subsequent vasospasm. Mdrs from this literature review: 2029214-2017-00283, 2029214-2017-00284, 2029214-2017-00285. 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 through literature review that after technical success with ped placement the lesion remained patent and tended to grow despite placement of 3 peds. There was, however, no re-rupture in this case despite a dual antiplatelet regimen and growth of the lesion. The patient was admitted with h<(>&<)>h grade 4 and a large sah (fisher grade 4). He also developed severe vasospasm, requiring multiple sessions of intra-arterial interventions. The patient never regained consciousness. He was made comfort-care by the family and eventually died 10 days after the initial hemorrhage. This patient presented with an aneurysmal subarachnoid hemorrhage (asah) which was found as a result of a ruptured blister aneurysm (ba) along the dorsum of the right internal carotid artery (ica). The aneurysm was located in the right ica measuring 1. 8mm. Mrs at sah was 5. The patient was started on dual antiplatelet therapy prior to placement of the ped. Vct 2 days after admission showed persistent filling of the blister-type aneurysm following placement of 4. 5×14 mm pipeline flow diverter. Lateral dsa post admission day 7 showed persistent filling of the blister-type aneurysm and multifocal vasospasm within the left anterior circulation following placement of 2 additional pipeline devices. The vasospasm required multiple sessions of intra-arterial interventions. The three ped 4x14 were placed without complications, however, there was persistent filling after the procedure and the patient died 10 days after the procedure. The patient died as a consequence of the original massive sah and subsequent severe vasospasm.
 
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
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 Key6445016
MDR Text Key71201486
Report Number2029214-2017-00283
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 03/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPED-450-14
Device Catalogue NumberPED-450-14
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 Received03/03/2017
Was Device Evaluated by Manufacturer? No
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: 03/29/2017 Patient Sequence Number: 1
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