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

Model Number FA-77250-12

Device Problem Restricted Flow rate (1248)

Patient Problems Neurological Deficit/Dysfunction (1982); Paresis (1998); Thrombosis (2100)

Event Date 01/26/2012

Event Type  Injury  

Event Description

Information received from the article: pistocchi s, blanc r, bartolini b, et al.Flow diverters at and beyond the level of the circle of willis for the treatment of intracranial aneurysms.Stroke 2012;43:1032-38.Medtronic (covidien) received information from literature review stating that one patient who was treated with a pipeline embolization device (ped) experienced permanent neurological complication.In this case, a left large (diameter 19.6 mm) middle cerebral artery (mca) aneurysm that had already recurred twice was treated for the third time with two peds and coils.The day after the procedure, the patient presented with sudden right hemiplegia and aphasia.An angiogram was immediately carried out showing complete ped thrombosis.Balloon angioplasty (an option presented in the instructions for use) was performed and the parent artery flow was restored.Despite that, the patient sustained a cerebral infarct with subsequent neurological deficit.

Manufacturer Narrative

The report was created to capture the complications involving the pipeline.The information was received from the article: pistocchi s, blanc r, bartolini b, et al.Flow diverters at and beyond the level of the circle of willis for the treatment of intracranial aneurysms.Stroke 2012;43:1032-38.Http://stroke.Ahajournals.Org/content/43/4/1032 the device will not be returned as it was implanted in the patient.The lot history record review was not possible as the lot number was not reported.(b)(4).

• Brand Name: PIPELINE EMBOLIZATION DEVICE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): IRVINE; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9496801224
• MDR Report Key: 4659424
• MDR Text Key: 5685783
• Report Number: 2029214-2015-00341
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P100018.S004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FA-77250-12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2015
• 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): Other; Required Intervention