MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA PIPELINE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number UNKNOWN

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

Patient Problem Embolism (1829)

Event Type  Injury  

Manufacturer Narrative

Citation: world neurosurgery, pervinder bhogal, oliver ganslandt, hansjo¨ rg bazner et.Al.The fate of side branches covered by flow diverters results from 140 patients the purpose of this article is flow diverter stents (fds) are a recognized treatment option for intracranial aneurysms.There remain ongoing concerns regarding the safety of fds, especially regarding the fate of covered side branches.This article reports the patency of side branches covered by fds.The article identified 140 patients, with 147 aneurysms, the mean average age was 56.2 +/- 13.7 years, male patient 31(21.9%).The devices will not be returned for evaluation as they remain implanted; therefore, no definitive conclusion can be drawn regarding the clinical observation.However, there is no evidence suggesting that the device was defective, but rather a patient's condition.Additional information has been requested from the author of this article regarding this case.Should it become available a supplemental report will be submitted.Related mdrs for this event: 2029214-2017-00885 2029214-2017-00886.

Event Description

Medtronic received information through literature review that approximately 18 months after implanting 2 pipeline embolization devices (peds) to treat an incidental achoa aneurysm, the patient was advised to stop clopidogrel and there were no complications.However, 1 year later, the patient discontinued aspirin and reported vague visual symptoms.Angiography showed minor thrombi adherent to the posterior-inferior wall of the ped.Mri performed on the same day showed multiple restricted diffusion deficits consistent with emboli.The patient was immediately restarted on aspirin and prasurgrel.Repeat angiogram 1 week later showed resolution of the thrombus.The patient was asymptomatic (mrs score, 0).

• Brand Name: PIPELINE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9498373700
• MDR Report Key: 6703162
• MDR Text Key: 79732760
• Report Number: 2029214-2017-00886
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100018.S011
• 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: 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2017
• 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
• Patient Age: 45 YR