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

Model Number PED-500-25

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 01/25/2018

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex has been returned and evaluation is in progress.A follow-up mdr will be submitted when device investigation is complete.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that vinyl polymer was found on a pipeline flex pushwire after use.The patient was undergoing flow diversion treatment of a 12mm aneurysm in the carotid siphon of the internal carotid artery (ica).The vessel was reportedly moderately tortuous.It is not known whether the devices were prepared as indicated in the ifu.During the procedure, the pipeline flex braid was placed in the desired location.It is not known whether issues such as resistance were encountered during delivery or placement of the pipeline flex.The pipeline flex pushwire was removed from the patient.It was reported that after removal, the physician "found a piece of vinyl polymer" attached to the pushwire.There were no reports of patient injury in association with this event.

Manufacturer Narrative

Additional information, device evaluation the pipeline flex pushwire was returned for evaluation; the pipeline flex braid remains implanted in the patient and was not returned.As received, the distal hypotube was found severely stretched.The tubing jacket was found to be stretched and peeled off from the hypotube for the length of approximately 64 cm.The pushwire was found to be bent approximately 13 to 20 cm from the proximal end.Based on the customer¿s photos and analysis findings, the report of pipeline flex pushwire damage was confirmed.It is possible that the patient's moderate vessel tortuosity contributed to the resistance during delivery, subsequently causing the pipeline flex pushwire to become damaged.The damage observed on the proximal wire (bending), ptfe shrink tubing jacket (stretching/peeling off) and hypotube (stretching) suggest that excessive force was used (pushing and pulling).In areas that the laser-cut hypotube was stretched, the resultant decrease in hypotube outer diameter (od) led to a loosening of the ptfe heat shrink jacket.The locations on the hypotube most severely damaged by stretching correspond to the areas of significant damage to the ptfe jacket.The root cause is believed to be the application of excessive force when delivering the pipeline flex leading to a stretched hypotube, which stripped the ptfe heat shrink off of the stretched sections of hypotube.Per the pipeline flex instructions for use (ifu), the user should ¿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 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.¿ the lot history record of the reported lot number showed no quality issues against the lot.No evidence was found to suggest 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): 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 ; 9496801224
• MDR Report Key: 7280647
• MDR Text Key: 100510228
• Report Number: 2029214-2018-00117
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2020
• Device Model Number: PED-500-25
• Device Lot Number: A517508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2017
• 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: 61 YR