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

Model Number PED-375-20

Device Problems Unintended Ejection (1234); Adverse Event Without Identified Device or Use Problem (2993); Physical Resistance/Sticking (4012)

Patient Problem Fistula (1862)

Event Date 08/19/2019

Event Type  Injury  

Manufacturer Narrative

The pipeline flex has not been returned for evaluation; product analysis cannot be performed.The device was not returned; the reported event could not be confirmed.The cause of the event could not be conclusively determined from the reported information.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that a cavernous carotid fistula (ccf) was developed during intervention.The patient was undergoing treatment for an aneurysm in the communicating segment.The devices were prepared and used per the instru ctions for use (ifu).The catheter was flushed as per the ifu.It was reported that during the procedure, the pipeline flex was advanced through the marksman with noted difficulty.When the pipeline flex reached the distal end of the marksman, it was reported that several attempts were made to deploy the device without success.The pipeline flex was removed.Afterward, a control angiogram was performed revealing a cavernous carotid fistula (ccf).It was reported that the ccf occurred due to the force implemented to remove the device.A new flow diversion device was placed to cover the ccf.The patient was reported to be asymptomatic, and extended hospitalization was not required.

• Brand Name: PIPELINE FLEX
• 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 ; 9496801345
• MDR Report Key: 9088542
• MDR Text Key: 161428788
• Report Number: 2029214-2019-00939
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2021
• Device Model Number: PED-375-20
• Device Lot Number: A684089
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2019
• Date Device Manufactured: 07/30/2018
• 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: 54 YR