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 Ischemia (1942); Thrombosis (2100); Vasoconstriction (2126)

Event Type  Injury  

Manufacturer Narrative

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).Linked mdr: 2029214-2019-00710.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received the following report through literature review of ¿flow diversion covering the m1 origin as a last resort¿ (li-mei lin, matthew t bender, geoffrey p colby, bowen jiang, jessica k campos, david a zarrin, robert w c young, risheng xu, justin m caplan, judy huang, rafael j tamargo, alexander l coon) most patients were female (7/9, 78%) and most aneurysms were right-sided (78%).A single pipeline embolization device (ped) device was used in all cases and adjunctive coiling was performed in four cases (44%).Intra-arterial verapamil was administered for spasmolysis in one case (11%), balloon angioplasty was not performed (0%) and platelet aggregation along the stent was observed in three cases (33%).Two of these were observed intra procedurally and resolved with abciximab administration.One patient (case 5) awoke with aphasia and hemiparesis; immediate dsa demonstrated platelet plugging at the orifice of the covered m1 which resolved with intra-arterial abciximab and complete resolution of clinical deficits.Two patients (22%) experienced complications resulting in permanent neurological deficit, including one major stroke that led to mortality (11%)and one minor stroke (11%).Case 6 was a cinquagenarian smoker with 3 mm proximal right a1 aneurysm treated with ped after unsuccessful attempted stent-coiling.The patient received intra-arterial abciximab at procedure end for delayed filling of the covered right mca.The patient had some left upper extremity weakness on awakening, which resolved with blood pressure augmentation.On postoperative day one in the intensive care unit, the patient developed left upper extremity weakness after an episode of vasovagal hypotension that occurred during removal of the femoral sheath.Mri showed scattered mca territory ischaemia and the patient was mrs 2 at last follow-up.Patients were followed clinically for an average of 27 months.Follow-up dsa showed complete aneurysm occlusion in 7/8 cases (88%) at an average interval of 21 months.Follow-up dsa was performed in all living patients at 6 months, 88% at 12 months and 50% at 24 months.The covered mca showed no delay or minimal delay (arterial phase filling) in 50% of cases (case 4), moderate delay with primarily anterograde flow in 25% of cases (case 5) and significant delay (reliance primarily on aca and external carotid artery (eca) collaterals) in 25% (case 1).No complications were observed beyond the initial 48 hours following embolization over 27 months of clinical follow-up, even with diminution of the mca and reliance on collateral supply from the aca or eca in half of cases.

• Brand Name: PIPELINE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA
• Manufacturer Contact: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 7635263305
• MDR Report Key: 8776415
• MDR Text Key: 150573740
• Report Number: 2029214-2019-00711
• 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

• 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
• Initial Date Manufacturer Received: 06/13/2019
• Initial Date FDA Received: 07/10/2019
• 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
• Patient Outcome(s): Required Intervention