MAUDE Adverse Event Report: MEDTRONIC COVIDIEN PIPELINE FLEX; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED-500-14

Device Problem Activation Failure (3270)

Patient Problem Intimal Dissection (1333)

Event Date 03/07/2017

Event Type  malfunction  

Manufacturer Narrative

The device will not be returned for analysis as it was implanted in the patient.We are unable to definitively determine the cause for the reported experience.However, this patient had severe vessel tortuosity.The pipeline flex ifu, states, "do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis." mdrs related to this report.2029214-2017-00369 2029214-2017-00370.

Event Description

Medtronic received information that during treatment of an aneurysm two pipeline devices did not open distally as the patient had severe vessel tortuosity.It was noted that the middle section of the first pipeline (ped-500-16) was positioned on a bend and less than 50 % was deployed when it failed to open.The pipeline was resheathed more than 2 times and removed from the patient with the microcatheter.A new pipeline (ped-500-14) and microcatheter were used and the second pipeline also did not open distally.Balloon angioplasty was performed to ensure wall apposition and vessel dissection occurred during dilatation of a non-medtronic balloon catheter.It was further reported that the balloon was inflated 4-5 times.Post angiographic result showed extravasation of vessel.

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): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9498373700
• MDR Report Key: 6459002
• MDR Text Key: 71827479
• Report Number: 2029214-2017-00370
• 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: 03/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED-500-14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2017
• 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): Other