MAUDE Adverse Event Report: MEDTRONIC COVIDIEN PIPELINE EMBOL. DEVICE 5.00MM X 20MM; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number FA-77500-20

Device Problem Positioning Failure (1158)

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

Event Date 10/26/2016

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation.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.

Event Description

Medtronic received information that during treatment of an aneurysm located in the internal carotid artery (ica), the physician prepared to release the device, but found the "head" of the device could not be opened.It was reported that the physician made numerous maneuvers without success.A new pipeline device was used to complete the surgery.No patient injury was reported.The diameter of the aneurysm was 5.6mmx6mm.The distal landing zone was 4.1 mm and the proximal was 4.97 mm.

Manufacturer Narrative

The pipeline pushwire was returned for evaluation without the pipeline braid.The pushwire was observed and found to have a bend within the capture coil and at 25.0cm from the distal tip coil.No other anomalies were observed.Based on the analysis findings the clinical observation could not be confirmed.The pipeline braid was not returned for evaluation, therefore any contributing factors from the pipeline braid could not be assessed.We are unable to definitively determine the cause for the reported experience.It is possible that the "pushwire bend" within the capture coil may have contributed to the reported experience.However, the cause for the damages could not be determined.Per the pipeline instructions for use (ifu): ¿detachment can be facilitated by slowly rotating the delivery wire in the clockwise direction and/or manipulating the microcatheter by locking down the delivery wire and moving both as a system.If the capture coil tip of the delivery system becomes stuck in the mesh of a delivered ped, rotate the wire clockwise while advancing the wire to try to release it, then slowly pull back on the delivery wire in addition, the lot history record of the reported lot number has been reviewed.The lot history record review showed no discrepancies that would have contributed to the reported experience.All products are 100% inspected for damage and irregularities during manufacture.

Manufacturer Narrative

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

• Brand Name: PIPELINE EMBOL. DEVICE 5.00MM X 20MM
• 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: 6130253
• MDR Text Key: 61027785
• Report Number: 2029214-2016-01064
• 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: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2019
• Device Model Number: FA-77500-20
• Device Lot Number: A216380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2016
• 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 Outcome(s): Congenital Anomaly
• Patient Age: 47 YR