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

Model Number NV UNK PIPELINE

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

Patient Problems Death (1802); Ischemia (1942); Neurological Deficit/Dysfunction (1982)

Event Type  Death  

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.Death is a 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 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%).Case 3 was a septuagenarian with 8 mm proximal left a1 aneurysm treated with ped and coiling.Post-treatment angiography showed slight left mca delay which resolved with blood pressure augmentation; however, hypotension during management of a retroperitoneal hematoma requiring surgical repair led to left mca stroke ultimately resulting in death.

• 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: 8776403
• MDR Text Key: 150573838
• Report Number: 2029214-2019-00710
• 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
• Device Model Number: NV UNK PIPELINE
• 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
• Patient Outcome(s): Death; Required Intervention