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

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

Patient Problems Occlusion (1984); Loss of Vision (2139); Stenosis (2263); Vascular Dissection (3160)

Event Type  Injury  

Manufacturer Narrative

The device was implanted and not returned for analysis.Based on the reported information, there is no evidence suggesting that the device was defective, but rather a post procedure related event.Since the device was not returned, we are unable to perform further root cause analysis.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.The reported adverse events are known inherent risk of endovascular procedure and are documented in our device¿s instruction for use (ifu).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report through literature review of ¿`plug and pipe¿ strategy for treatment of ruptured intracranial aneurysms¿ (brian m howard, jason m frerich, thomas p madaelil, jacques e dion, frank c tong, c michael cawley, jonathan a grossberg).22 patients underwent acute phase coiling of an aneurysm after asah; 21 patients suffered sah from a ruptured saccular aneurysm, while 1 was treated for an iatrogenic, medial wall, carotid cave ica pseudoaneurysm caused during endoscopic, endonasal pituitary adenomectomy.The population was predominantly female (n=19, 86%).The median age of the study population was 57 years (iqr 49.3, 64.5; range 36¿83).All aneurysms were primary coiled at the time of their asah without any intraoperative rupture or thromboembolic complications.Complications, as a result of flow diversion, occurred in two (9%) patients.One patient suffered monocular blindness as a consequence of ophthalmic artery occlusion.The second suffered an inferior epigastric artery avulsion and external iliac artery dissection that required an operative bypass by vascular surgery.No patients suffered re-hemorrhage in the interval between coiling and ped placement, or after ped placement.No patient in the study population died.On follow up, there was note of one case in-stenosis.

• Brand Name: PIPELINE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 7635263305
• MDR Report Key: 8778615
• MDR Text Key: 150684589
• Report Number: 2029214-2019-00720
• 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: Physician
• Type of Report: Initial
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• 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: 06/13/2019
• 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