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

Device Problem Restricted Flow rate (1248)

Patient Problems Headache (1880); Stenosis (2263)

Event Type  Injury  

Event Description

Information received from the article: ding et al.Endovascular treatment of recurrent intracranial aneurysms following previous microsurgical clipping with the pipeline embolization device.Journal of clinical neuroscience.21 (2014), 1241-1244.Medtronic (covidien) received information regarding a manufactured product and adverse event through literature review.Treatment of a large fusiform aneurysm located in the supraclinoid segment of the right ica (internal carotid artery).The patient underwent pipeline embolization treatment without any issues.At seven months, angiography revealed complete aneurysm obliteration with moderate in-stent stenosis.At eleven months, angiography showed complete resolution of the in-stent stenosis without evidence of residual aneurysm however the patient was experiencing chronic headaches and was neurologically stable.The article emphasized the importance of close angiographic surveillance after aneurysm treatment, even in patients who have undergone microsurgical clipping.

Manufacturer Narrative

The report was created to capture the in-stent stenosis.The information was received from the article: ding et al.Endovascular treatment of recurrent intracranial aneurysms following previous microsurgical clipping with the pipeline embolization device.Journal of clinical neuroscience.21 (2014), 1241-1244.The lot history record review was not possible since the lot number was not reported.The device will not be returned as it was implanted in the patient.(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): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: 9775 toledo way; irvine, CA 92618 ; 9496801224
• MDR Report Key: 4541897
• MDR Text Key: 5353146
• Report Number: 2029214-2015-00195
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2015
• 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: 01/26/2015
• 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
• Patient Age: 45 YR