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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Infarction, Cerebral (1771); Neurological Deficit/Dysfunction (1982); Thromboembolism (2654)

Event Date 03/01/2015

Event Type  Injury  

Manufacturer Narrative

Citation: martínez-galdámez m, pérez s,vega a, et al.Endovascular treatment of intracranial aneurysms using the pipeline flex embolization device: a case series of 30 consecutive patients.J neurointervent surg 2016;8:396¿401.The device 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 cause was unknown.

Event Description

Medtronic received information through review of literature cases involving four intraprocedural/periprocedural complications occurred, of which 2 resulted in major complications, with neurologic deficits persisting for longer than 7 days.Both major neurologic events (cases 23 and 26) were ischemic infarcts at anterior choroidal arteries in large aneurysms, where two devices were overlapped.There were two intraprocedural events with no clinical relevance.In case 25 (located at the m1 segment of the mca), an acute occlusion of an early frontal branch of the mca occurred during hypotension, which resolved after increasing the arterial pressure and an intra-arterial bolus (5 mg) of abciximab (reopro).In case 28, an intraprocedural mild in-stent thrombus occurred in a patient with borderline-hyporesponse to aspirin, which resolved with an intra-arterial bolus of abciximab (10 mg) (by increasing the dose of aspirin from 100 to 300 mg daily a normal response range was achieved).

• Brand Name: PIPELINE FLEX EMBOLIZATION DEVICE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9498373700
• MDR Report Key: 5757184
• MDR Text Key: 48399706
• Report Number: 2029214-2016-00475
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P100018.S004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention