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

Model Number PED2-450-20

Device Problem Activation Failure (3270)

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

Event Date 11/29/2017

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for analysis.Attempts have been made but no response has been received.Per our instructions for use (ifu): ¿begin to deliver the device using a combination of unsheathing the embolization device and pushing delivery wire simultaneously.After the distal end of the embolization device has successfully expanded, deploy the remainder of embolization device by pushing the delivery wire and/or unsheathing the embolization device.Re-sheathing and/or manipulation of the micro catheter, by locking down the delivery wire and moving both as a system, may facilitate expansion of the embolization device.It is not recommended to initiate deployment of the device on a bend.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.¿ all products are 100% inspected for damages and irregularities during manufacture.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that during the treatment of a right, unruptured internal carotid artery aneurysm, the flow diverter device failed to open.

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• 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 ; 9492753836
• MDR Report Key: 7129705
• MDR Text Key: 95825774
• Report Number: 2029214-2017-01366
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/05/2018
• Device Model Number: PED2-450-20
• Device Lot Number: A084901
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/29/2017
• Initial Date FDA Received: 12/19/2017
• Date Device Manufactured: 04/06/2015
• 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 Age: 69 YR