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

Model Number PED-475-25

Device Problems Difficult to Open or Close (2921); Activation Failure (3270)

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

Event Date 07/01/2018

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex embolization device has not been returned for evaluation; product analysis cannot be performed.The device was not returned, therefore the reported event could not be confirmed.The cause of the event cannot be conclusively determined from the provided information.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during embolization this pipeline flex embolization device did not open at the distal end.The patient underwent embolization treatment for a medium unruptured saccular aneurysm located in left internal carotid artery cavernous segment.Measuring 20mmx12mm, landing zone distal 4mm proximal 4.5mm.It was reported that while the physician tried to unsheathe the device, distal braid not able to open in the vessel.The pipeline was resheathed and removed with the microcatheter from the patient.New device was replaced, and procedure was completed.There were not any patient symptoms or complications associated with this event.The vessel was normal tortuous.No patient injury was reported.

Manufacturer Narrative

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

Manufacturer Narrative

The clinical observation could not be confirmed.As received, only pipeline flex braid returned without pushwire.The distal and proximal ends of the pipeline flex braid appeared fully opened with moderately frayed.No other anomalies were observed.We were unable to determine the cause of failure to open during the procedure.The event cause could not be determined as the distal and proximal ends of the returned pipeline flex braid appeared fully opened with moderately frayed.The damage to the braid on the ends of the pipeline flex is likely the results of the customer re-sheathing the device more than recommended two times.All products are 100% inspected for damage and irregularities during manufacture.Per our instructions for use (ifu), the user should "begin to deliver the device using a combination of unsheathing the pipeline flex 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 embolization device.Re-sheathing the pipeline flex embolization device more than 2 full cycles may cause damage to the distal or proximal ends of the braid.Carefully inspect the deployed pipeline flex embolization device under fluoroscopy to confirm that it is completely apposed to the vessel wall and not kinked.If the device is not fully apposed or is kinked, consider using a balloon catheter, micro catheter, or guide-wire to fully open it.¿ if information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE FLEX EMBOLIZATION DEVICE
• 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: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9498373700
• MDR Report Key: 7711208
• MDR Text Key: 114944824
• Report Number: 2029214-2018-00641
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/26/2020
• Device Model Number: PED-475-25
• Device Lot Number: A482858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2017
• 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
• Patient Age: 72 YR