MAUDE Adverse Event Report: COVIDIEN PIPELINE EMBOLIZATION DEVICE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number NOT REPORTED

Device Problem Occlusion Within Device (1423)

Patient Problem Death (1802)

Event Type  Death  

Event Description

Information received from the article: fischer s, vajda z, aguilar m, et al.Pipeline embolization device (ped) for neurovascular reconstruction: initial experience in the treatment of 101 intracranial aneurysms and dissections.Neuroradiology (2012) 54:369¿382.Eighty-eight consecutive patients underwent pipeline embolization treatment between (b)(6) 2009 and (b)(6) 2011 for 101 intracranial aneurysms or dissections.Ninety-six aneurysms and five vessel dissections were treated.Multiple devices were implanted in 67 lesions.One mechanical failure was encountered in one procedure.Immediate exclusion of the target lesion was not observed.Angiographic follow-up examinations were done for 80 patients with 90 lesions revealing complete cure of the target lesion(s) in 47, morphological improvement in 32 lesions, and no improvement in 11 lesions.Six major complications were encountered: one fatal aneurysm rupture, one acute and one delayed pipeline thrombosis, and three hemorrhages in the dependent brain parenchyma.Patient 40: the patient presented with an incidentally found diffuse dilatation of the basilar artery bifurcation with a saccular component between the right superior cerebellar artery (sca) and posterior cerebral artery (pca) origins.Given the sca irregular shape of the dilatation and in view of the partially saccular aspect, it was considered a potential source of a future bleeding.On (b)(6) 2009, a solitaire ab stent was inserted into the left pca with the proximal end of the stent in the trunk of the basilar artery.On (b)(6) 2010, a pipeline was deployed from the right pca, crossing the solitaire stent at the level of the basilar bifurcation and extending with the proximal end into the trunk of the basilar artery.This procedure was tolerated well and the patient was discharged in his previous condition.He was told to continue the medication of asa and clopidogrel for 6 weeks and to continue with asa thereafter.Eight weeks after the treatment and 22 days after he had stopped the intake of clopidogrel, he was referred to another hospital and from there with some delay to us.At admission, the patient was comatose.Dsa (digital subtraction angiography) revealed the pipeline and the upper basilar artery filled with thrombus.Given the time interval from clinical onset to arrival at our hospital, local intra-arterial fibrinolysis was not considered a reasonable option.The attempted mechanical thrombectomy failed due to access issues, and subsequently, patient expired from the sequelae of brainstem infarct 27 days later.The information was received from the same article as mdr# 2029214-2015-00023 / 2029214-2015-00014 / 2029214-2015-00015 / 2029214-2015-00016 / 2029214-2015-00020.

Manufacturer Narrative

The lot history record review was not possible since the lot number was not reported.The device will not be returned for analysis as it was implanted in the patient; therefore, the event cause could not be determined.

• Brand Name: PIPELINE EMBOLIZATION DEVICE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): IRVINE; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: 9775 toledo way; irvine, CA 92618 ; 9496801558
• MDR Report Key: 4398855
• MDR Text Key: 5126719
• Report Number: 2029214-2015-00018
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100018.S004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/09/2014

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 Model Number: NOT REPORTED
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2014
• Initial Date FDA Received: 01/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 71 YR