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

Model Number FA-71450-25

Device Problem Positioning Failure (1158)

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

Event Date 01/03/2016

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 the device could not be deployed.It was reported that the microcatheter reached the target position and the device was unable to be deployed despite several attempts.A new device was used to complete the procedure.No patient injury was reported.No further information was provided.

Manufacturer Narrative

The pipeline delivery system and the pipeline braid were returned for evaluation.As received, the pipeline braid was found to be released from the capture coil.The pipeline braid was found to be fully open with no damages.No other anomalies were observed.The customer¿s clinical observation could not be confirmed.Based on the analysis we are unable to conclusively determine the cause of this event.All products are 100% inspected for damage and irregularities during manufacture.

• Brand Name: PIPELINE EMBOL. DEVICE
• 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: 5428098
• MDR Text Key: 37981593
• Report Number: 2029214-2016-00082
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 04/05/2016

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: Physician
• Device Expiration Date: 08/21/2017
• Device Model Number: FA-71450-25
• Device Catalogue Number: FA-71450-25
• Device Lot Number: 9958091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/17/2016
• Initial Date FDA Received: 02/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2014
• 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