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

Model Number FA-77275-20

Device Problem Positioning Failure (1158)

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

Event Date 04/17/2016

Event Type  Injury  

Manufacturer Narrative

The delivery system 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 delivery system be returned or additional information become available, a supplemental report will be submitted.

Event Description

Medtronic received information that during treatment the distal part of the device did not open, despite several attempts.The physician decided to withdraw the device and microcatheter together and in the process the device opened and fell into the aneurysm and currently remains in the patient.A second device was used and released successfully.The patient has been discharged from the hospital.

Manufacturer Narrative

The pipeline pushwire was returned for evaluation without the pipeline braid as it was implanted in the patient.As received, the capture coil appeared to be stretched.Based on the analysis findings the clinical observation could not be confirmed.We are unable to definitively determine the cause for the reported experience.It is possible that the damaged capture coil may have contributed to the reported issue.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.

• 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: 5670155
• MDR Text Key: 45616609
• Report Number: 2029214-2016-00328
• 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
• Report Date: 07/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/02/2018
• Device Model Number: FA-77275-20
• Device Lot Number: A156155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2016
• Initial Date FDA Received: 05/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2015
• 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 Outcome(s): Required Intervention