MAUDE Adverse Event Report: COVIDIEN (IRVINE) PIPELINE FLEX WITH SHIELD; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED2-450-16

Device Problems Retraction Problem (1536); Difficult to Open or Close (2921); Positioning Problem (3009); Activation Failure (3270)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/11/2018

Event Type  malfunction  

Manufacturer Narrative

The device has been received.However, the device analysis has yet not began.A supplemental report will be submitted.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that during the procedure, the pipeline was delivered to the intended location and deployed distally and failed to open and had to be repositioned.The pipeline then could not be sheathed, as the pipeline could not be pulled back into the microcatheter.It was decided to pull out pipeline and microcatheter together.There was resistance in the distal section of the catheter.There was no patient injury.The catheter was flushed continuously with heparinized saline.The devices were each prepared and used per the instructions for use (ifu).The anatomy was tortuous.

Manufacturer Narrative

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

Manufacturer Narrative

Based on the analysis findings, the event descriptions, the report of failure to open at the distal end was not confirmed as the distal end and proximal ends of the pipeline flex with shield braid appeared to be fully opened and moderately frayed.It¿s possible that the patient¿s vessel tortuosity may have contributed to the failure to open issue.The damage to the braid on the ends of the pipeline flex with shield is likely the results of the re-sheathing the device more than recommended two times.Regarding failure to resheath and resistance issues, the complaint was confirmed as the returned pipeline flex with shield appeared to be stuck at the distal segment of the catheter.The returned pipeline flex with shield and the catheter were found to be damaged.It was reported that the patient¿s vessel was tortuous.In addition, the devices were prepared per the instructions for use (ifu) and a continuous flush with heparinized saline was maintained during procedure.It¿s possible that the patient¿s vessel tortuosity may have contributed to the resistance during delivery.From the damages seen on the catheter body (stretching/accordioning), pipeline flex shield braid (fraying), proximal wire (bending) and hypotube (stretching); it appears there was high force used (pushing and pulling).It is likely these damages occurred when attempted to advance/retrieve the pipeline flex with shield through the microcatheter against the resistance.Per our instructions for use (ifu), the user should: ¿begin to deliver the device using a combination of unsheathing the pipeline flex with shield embolization device and pushing delivery wire simultaneously.After the distal end of the pipeline flex with shield has successfully expanded, deploy the remainder of the device.The system is designed to allow for 2 full cycles of re-sheathing of the pipeline flex with shield embolization device.Re-sheathing the pipeline flex with shield embolization device more than 2 full cycles may cause damage to the distal or proximal ends of the braid.Discontinue delivery of the device if high force or excessive friction is encountered during delivery.Identify the cause of the resistance and remove device and microcatheter simultaneously.Advancement of the ped against resistance may result in device damage or patient injury.Never advance or withdraw an intralumenal device against resistance until the cause of resistance is determined by fluoroscopy.If the cause cannot be determined, withdraw the catheter.Movement of the micro catheter against resistance may result in damage to the micro catheter, or the vessel.Do not use in pat ients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis.¿ all products are 100% inspected for damage and irregularities during manufacture.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

• Brand Name: PIPELINE FLEX WITH SHIELD
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: gabriela mclellan ; 9775 toledo way; irvine, CA 92618 ; 9492753836
• MDR Report Key: 7758700
• MDR Text Key: 116860656
• Report Number: 2029214-2018-00701
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100018.S011
• 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,Followup
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/23/2018
• Device Model Number: PED2-450-16
• Device Lot Number: A178217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1