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

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

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 09/15/2016

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis as it was implanted in the patient.Attempts have been made to obtain additional information, however, our attempts have been unsuccessful.Based on the reported information, the device initially performed as intended, as indicated by successful deployment of the device in the intended located.It is unknown what caused the aneurysm to be incompletely occluded and its cannot be reliably determined; however, per the reported information, the most likely cause for the complaint is the patient condition.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

Citation: collar sign in incompletely occluded aneurysms after pipeline embolization: evaluation with angiography and optical coherence tomography.Griessenauer cj1, gupta r2, shi s2, alturki a2, motiei-langroudi r2, adeeb n2, ogilvy cs2, thomas aj2.Ajnr am j neu roradiol.2017 feb;38(2):323-326.Doi: 10.3174/ajnr.A5010.Epub 2016 nov 10.Medtronic received report of 17 aneurysms that were incompletely occluded, 2 of these aneurysms underwent retreatment with a second flow diverter device.

• Brand Name: PIPELINE
• 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: medtronic miles ; 9775 toledo way; irvine, CA 92618 ; 9492753836
• MDR Report Key: 6448102
• MDR Text Key: 71323729
• Report Number: 2029214-2017-00289
• 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: health professional,literatur
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2017
• 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: 03/03/2017
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention