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

Model Number PED-500-25

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/22/2015

Event Type  malfunction  

Manufacturer Narrative

The device involved in this event will not be returned for evaluation as it was discarded at the site.The event cause could not be determined.(b)(4).

Event Description

Medtronic (covidien) received report that a pipeline flex did not open during treatment of a fusiform aneurysm in the distal, right, cavernous internal carotid artery (ica).The pipeline flex was deployed and landed distally with difficulty due to tortuous anatomy.The distal end of the pipeline flex was well apposed, but the middle third of the device did not open sufficiently through the aneurysm and cavernous sinus curve.Techniques to improve opening included using a support catheter, loading and unloading the system, pinning the microcatheter and pushing the wire, and resheathing the device two times.The middle section of the pipeline flex continued to be flattened and stretched through tortuous anatomy.The pipeline flex was resheathed and removed from the patient, then disposed of by staff.The case was rescheduled.Patient condition was stable post-procedure.

• Brand Name: PIPELINE FLEX EMBOLIZATION DEVICE
• 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 ; 9496801224
• MDR Report Key: 5004138
• MDR Text Key: 24615531
• Report Number: 2029214-2015-00885
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 07/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/19/2017
• Device Model Number: PED-500-25
• Device Lot Number: A005107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2014
• 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 Weight: 32