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

Model Number PED-375-10

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Infarction, Cerebral (1771); Hemorrhage, Subarachnoid (1893); Neurological Deficit/Dysfunction (1982); Vasoconstriction (2126); Therapeutic Response, Decreased (2271)

Event Date 08/18/2014

Event Type  Injury  

Manufacturer Narrative

Heit, j.J., telischak, n.A., do, h.M., dodd, r.L., steinberg, g.K., <(>&<)> marks, m.P.(2017).Pipeline embolization device retraction and foreshortening after internal carotid artery blister aneurysm treatment.Interventional neuroradiology.Doi:10.1177/1591019917722514 the pipeline flex device remains implanted in the patient; product analysis cannot be performed.It should be noted that the ped was placed in the treatment of a ruptured, blister aneurysm, for which the device is not indicated for use.The article states that the patient likely had an underlying connective tissue disorder resulting in changes in ica vessel caliber; the increased vessel caliber led to retraction (foreshortening) of the ped.Based on the provided information, foreshortening does not appear to have been due to any defect of the device.In addition, the article states that the patient experienced vasospasm resulting in cerebral infarction and neurological deficits.The cause of the vasospasm could not be conclusively determined from the provided information.Mdrs related to this article: 2029214-2017-01077 2029214-2017-01078.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 literature review found a report of pipeline retraction and foreshortening after placement.A middle-aged patient presented with severe headache due to subarachnoid hemorrhage (hunt and hess scale score 2, glasgow come scale 15, fisher grade score 3).Digital subtraction angiography (dsa) identified a left internal carotid artery (ica) blister aneurysm and bilateral cervical ica dissections.The decision was made to proceed with endovascular treatment using flow diversion devices.On dsa, the left ica diameter proximal to the aneurysm was 3.6mm.Two telescoping pipeline embolization devices (ped) were placed across the aneurysm.The first ped (3.75x12mm) was placed 2mm distal to the edge of the blister aneurysm and 1mm proximal to the origin of the anterior choroidal artery.A second ped (3.75x10mm) was placed 5mm distal to the distal edge of the first ped (just proximal to the ica terminus) and the proximal aspect of the second ped terminated with the first ped proximal to the blister aneurysm.Dual antiplatelet therapy (aspirin 81mg, clopidogrel 75mg daily) was initiated at the time of treatment with a 24-hour intravenous eptifibatide bridge.The patient reportedly did well immediately after treatment, but became unresponsive five days after treatment.Head ct showed new subarachnoid hemorrhage.Antiplatelet medications were ceased and platelets were administered.A second dsa showed increased diameter of the supraclinoid ica (which measured 5.2mm proximal to the aneurysm) and increased aneurysm size.The two peds had retracted by 6mm and there was increased growth of the aneurysm.The patient underwent successful balloon test occlusion followed by endovascular parent vessel occlusion for aneurysm treatment.The patient was then transferred to the operating room where an uncomplicated direct left external carotid artery to middle cerebral artery bypass surgery was performed to provide additional blood flow to the left anterior circulation in the event that the patient developed vasospasm.Two days after vessel sacrifice, the patient developed severe vasospasm despite aggressive endovascular treatment with intraarterial nicardipine and cerebral angioplasty of the contralateral right supraclinoid ica, a2, m1.The vasospasm resulted in cerebral infarction.The patient survived, but was left with neurologic deficits that included receptive and expressive aphasia as well as right hemiplegia.Per the reporting author, this event was not device failure, but rather a lesson about sizing in off-label use of the ped.The authors reports that device lot numbers are not available.

• Brand Name: PIPELINE FLEX EMBOLIZATION DEVICE
• 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 ; 9496801224
• MDR Report Key: 6899235
• MDR Text Key: 87587412
• Report Number: 2029214-2017-01078
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PED-375-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2017
• 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): Other; Required Intervention
• Patient Age: 48 YR
• Patient Weight: 82