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 Problem Ecchymosis (1818)

Event Date 10/08/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

González a, ortega-quintanilla j, zapata-arriaza e, et al.Dose adjustment of clopidogrel in hyper-responder patients with unruptured intracranial aneurysms treated with stents.Journal of neurointerventional surgery.2020;12(5):499-504.Doi:10.1136/neurintsurg-2019-015288.20 patients with 24 unruptured intracranial aneurysms were identified as clopidogrel hyper-responders (pru =80).Mean age was 54.6 years (range 42¿74) and 85% were women.Patient #4 was treated with 2 pipeline devices and was reported to have post procedure reproductive system bleeding.The aneurysm was reported to have occluded.Patient #11 was reported to have stenosis intrastent at 12 months and the aneurysm was occluded.Patient #15 was reported to have experienced atraumatic ankle hematoma and the aneurysm was occluded.Patient #17 experienced epistaxis post the procedure and the aneurysm was occluded.One of the patients (after 5 days of treatment) required medical treatment with a blood transfusion.

• 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: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 7635140379
• MDR Report Key: 10340032
• MDR Text Key: 205100943
• Report Number: 2029214-2020-00746
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• 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: 07/21/2020
• 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