MAUDE Adverse Event Report: MEDTRONIC COVIDIEN PIPELINE EMBOL. DEVICE 4.00MM X 25MM; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number FA-71400-25

Device Problems Positioning Failure (1158); Activation Failure (3270)

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

Event Date 03/25/2016

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation; however, return is anticipated.Without return of the device, no definitive conclusions can be drawn regarding the clinical observation.Should the device be returned or additional information become available, a supplemental report will be submitted.Information received from the same report as mfr: 2029214-2016-00238.

Event Description

Medtronic received information that the "head could not open in processing." the physician withdrew the system and used a second device and encountered the same problem.A new device was used to complete the surgery successfully.No patient injury was reported.

Manufacturer Narrative

The device will not be returned for evaluation.Without return of the device, no definitive conclusions can be drawn regarding the clinical observation.

Event Description

Medtronic received additional information that two devices could not be released from the protective capture coil.The pushwires were rotated no more than 10 times.The physician withdrew the systems and a new device was used to complete the procedure.No patient injury was reported.The aneurysm, located in the left ophthalmic segment of the left internal carotid artery.It was of an irregular shape with max diameter of 7 mm.The distal landing zone was 4.19 mm and the proximal was 3.8 mm.The neck was 7mm x 6mm.The patient had moderate vessel tortuosity.

Manufacturer Narrative

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

• Brand Name: PIPELINE EMBOL. DEVICE 4.00MM X 25MM
• 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: 5594532
• MDR Text Key: 43226576
• Report Number: 2029214-2016-00239
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P100018.S004
• 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,Followup,Followup
• Report Date: 08/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/12/2018
• Device Model Number: FA-71400-25
• Device Lot Number: A132272
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2016
• Date Device Manufactured: 07/13/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 00048 YR
• Patient Weight: 66