MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR PIPELINE FLEX EMBOLIZATION DEVICE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED-500-16

Device Problems Material Frayed (1262); Activation Failure (3270)

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

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex with shield had not been returned for evaluation; product analysis cannot be performed.The device was not returned; the reported event could not be confirmed.The cause of the event could not be conclusively determined from the reported information.Suspect medical device brand name: pipeline flex with shield technology, model number: ped2-500-16.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report of pipeline flex with shield failure to open.The patient was undergoing embolization of an unruptured saccular aneurysm measuring 3mm x 3mm located in the cavernous segment of the left internal carotid artery (ica).The distal and proximal landing zone was 4mm x 5mm and the patient¿s vasculature was normal in tortuosity.The reported device and ancillary devices were prepared as indicated in the instructions for use (ifu).It reported that during the procedure, the pipeline flex with shield was deployed; more than 50% of the pipeline flex braid had been deployed when the distal end was observed not to open.The device had not been deployed in a vessel bend.The physician resheathed and re-deployed the device in an attempt to open it; these attempts were unsuccessful.The pipeline flex with shield was resheathed and removed from the patient with the microcatheter.After removal from the patient, the distal end of the braid was observed to have fraying damage.Another pipeline was successfully deployed with good angiographic results.No patient injury was reported as a result of the event.

Manufacturer Narrative

The pipeline flex shield braid was returned for evaluation without the pushwire as it was likely discarded; therefore, the distal and proximal ends of the braid were unable to be identified.The pipeline flex shield braid appeared fully opened and moderately frayed at both ends.No other anomalies were observed.The product analysis does not indicate a potential or confirm manufacturing issue; therefore, no lot history record review is required.Based on the analysis findings, the customer report of ¿failure to open at the distal end¿ could not be confirmed and the event cause could not be determined as the returned pipeline flex shield braid was found fully opened with moderately frayed at both ends.Possible contributing factors include damaged braid and patient¿s vessel tortuosity.The damage to the braid on the ends of the pipeline flex shield is likely the results of the customer re-sheathing the device more than recommended two times.Per our instructions for use (fu): "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 embolization device has successfully expanded, deploy the remainder of pipeline flex embolization device by pushing the delivery wire and/or unsheathing the pipeline flex embolization device.Re-sheathing and/or manipulation of the micro catheter, by locking down the delivery wire and moving both as a system, may facilitate expansion of the pipeline flex embolization device.Carefully inspect the deployed pipeline flex embolization device under fluoroscopy to confirm that it is completely opposed 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.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.Do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis.¿ no evidence was found to indicate that the device failed to meet specifications; therefore, manufacturing has been ruled out as a potential cause.All products are 100% inspected for damage and irregularities during manufacture.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): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9496801224
• MDR Report Key: 7612088
• MDR Text Key: 111443009
• Report Number: 2029214-2018-00557
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 09/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2020
• Device Model Number: PED-500-16
• Device Lot Number: A419004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2017
• 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: 39 YR