MAUDE Adverse Event Report: COVIDIEN (IRVINE) PIPELINE FLEX; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED-475-14

Device Problems Difficult to Open or Close (2921); Activation Failure (3270); Physical Resistance/Sticking (4012)

Patient Problems Aneurysm (1708); No Known Impact Or Consequence To Patient (2692)

Event Date 06/28/2018

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex embolization device will not be returned for evaluation as it was discarded; therefore, product analysis cannot be performed.The device was not returned, therefore the reported event could not be confirmed.The cause of the event cannot be conclusively determined from the provided information.Related mdrs for this event: 2029214-2018-00653 and 2029214-2018-00654 if information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that the first pipeline flex embolization device would not open on the distal end during the treatment of a blister aneurysm located in the cavernous segment of the internal carotid artery(ica).It was reported that pipeline was removed from the patient.It was stuck in the microcatheter, but the distal segment still would not open.The physician chose another pipeline flex embolization device, but this pipeline became kink and would not open.This pipeline was also stuck in the microcatheter and removed from the patient.The patient was treated with another pipeline and was reported to be fine post procedure and went home the same day.No patient injury was reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE FLEX
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9498373700
• MDR Report Key: 7719894
• MDR Text Key: 115367560
• Report Number: 2029214-2018-00654
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/07/2021
• Device Model Number: PED-475-14
• Device Lot Number: A641849
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/08/2018
• 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