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

Model Number FA-71500-25

Device Problem Positioning Failure (1158)

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

Event Date 12/18/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.

Event Description

Medtronic received information that during treatment of aneurysm located in the right cavernous sinus, ophthalmic artery, the device could not be released from the capture coil.It was reported the physician rotated the pushwire more than ten times in effort to release the device but was unsuccessful.The device was then retracted and another device was used to complete the surgery successfully.No patient injury was reported.

Manufacturer Narrative

The pipeline braid was returned for evaluation without the pushwire.As received 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.No other anomalies were observed.Based on the analysis findings the clinical observation could not be confirmed.We are unable to definitively determine the cause for the reported experience.However, it is possible that the rotating of the pushwire more than the recommended ten times, and the damaged braid may have contributed to reported experience.However, the cause for the damage could not be determined.As per the instructions for use (ifu): ¿never rotate the delivery wire more than 10 full turns.If ped does not open after 10 turns, remove the entire system (micro catheter and ped delivery system together).¿ 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: 5384525
• MDR Text Key: 36587916
• Report Number: 2029214-2016-00037
• 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: 07/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/15/2018
• Device Model Number: FA-71500-25
• Device Lot Number: A134224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2015
• 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: 00050 YR
• Patient Weight: 65