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

Model Number FA-77425-18

Device Problem Positioning Failure (1158)

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

Event Date 03/04/2016

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation.Therefore, no definitive conclusions can be drawn regarding the clinical observation.Follow up attempts are being made to gather more information and device status.Should the device be returned or additional information become available, a supplemental report will be submitted.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during treatment of an aneurysm located in the internal carotid artery the device could not be opened.It was reported that the physician tried several times to open the end of the stent in capture coil, but was unsuccessful.The physician withdrew the device with the microcatheter and a new device was used to complete the procedure.No patient injury was reported, the patient current status is stable.

Manufacturer Narrative

The pipeline braid and pushwire were returned for evaluation.As received, the pipeline was found to be released from the capture coil; therefore the distal and proximal ends of the pipeline braid could not be determined.The pipeline braid was observed to be fully open with both ends having slight fraying.The capture coil was also found to be bent.Based on the analysis findings the clinical observation could not be confirmed.We are unable to definitively determine the cause of this event.It¿s possible that the, damaged capture coil and the braid being undersized to the distal landing zone may have contributed to the reported issue.However, the cause for the damages could not be determined.Per the instructions for use (ifu): ¿choose a ped with labeled diameter that approximates the target vessel diameter.¿ in addition, a review of this device lot history record was conducted and no issues were identified that could have contributed to this event.All products are 100% inspected for damage and irregularities during manufacture.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The proximal landing zone was 3.81 mm and the distal was 4.72 mm.

Manufacturer Narrative

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

• Brand Name: PIPELINE
• 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: 5537933
• MDR Text Key: 41554658
• Report Number: 2029214-2016-00185
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• 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: 07/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/26/2018
• Device Model Number: FA-77425-18
• Device Lot Number: A049106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2015
• 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: 00058 YR