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

Model Number PED-400-12

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 04/19/2016

Event Type  Injury  

Manufacturer Narrative

The pipeline flex delivery system was returned for evaluation with the catheter.The guide catheter was not returned; any contributing factors from the guide catheter could not be assessed.As received, the pipeline flex delivery system was found outside of the catheter.The pushwire was found to be detached at the distal hypotube proximal to the wire weld.The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.The pushwire appeared to be bent at near the distal tip coil as well as at a section near the proximal end.Based on the reported event details and the analysis findings, the report pipeline flex pushwire detachment was confirmed.The returned devices were found to be severely damaged.It is likely that the pushwire detachment occurred due to tensile overload exceeding the strength of the solder joint.It is possible that the resistance during retrieval may have contributed to the reported issues.The damages seen on the distal <(>&<)> proximal wire (bending), hypotube (stretching) and catheter (accordion) indicate that excessive forced was used.The resistance may have prevented the pushwire from pulling through the catheter lumen, subsequently causing the pushwire to become detached.However, the cause for the resistance could not be conclusively determined.Per our instructions for use, 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 intraluminal 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.¿ the lot history record of the reported lot number was reviewed and no discrepancies that might have caused the reported event were noted.All products are 100% inspected for damage and irregularities during manufacture.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that a pipeline flex pushwire detached during a procedure.The patient was undergoing treatment of an unruptured, saccular aneurysm in the left ophthalmic internal carotid artery (ica).The aneurysm had a max diameter of 4mm and neck diameter of 3mm.Landing zone artery size was 3.5mm distal and 4.2mm proximal.The aneurysm had been previously treated with another manufacturer's coils.Vessel tortuosity was normal.The devices were prepared as indicated in the ifu.The pipeline flex was delivered.The device was never resheathed.It was reported that at retrieval of the delivery wire, the ptfe sleeves became stuck outside of the catheter and prevented retrieval of the tip coil.The physician tried to retrieve the catheter and delivery wire back into the guide catheter, but was unable to.The physician then tried to retrieve the guide catheter, catheter, and delivery wire into the sheath, but was unable to.During the retrieval attempts, the delivery wire detached at the proximal marker.The detached piece was in the aorta.A microsnare was unsuccessful in retrieving the piece and pushed it closer to the iliac artery.A different retrieval device was attempted; the physician was able to grasp the wire and pull it into the sheath.There was no report of patient injury as a result of this event.The post-procedure angiographic result showed slowing of flow into the aneurysm.

Manufacturer Narrative

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: 5656057
• MDR Text Key: 45210595
• Report Number: 2029214-2016-00306
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2018
• Device Model Number: PED-400-12
• Device Lot Number: A078971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2016
• Initial Date FDA Received: 05/16/2016
• Supplement Dates Manufacturer Received: 04/19/2016
• Supplement Dates FDA Received: 09/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 94