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

Model Number PED-475-18

Device Problems Difficult To Position (1467); Physical Resistance (2578); Activation Failure (3270)

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

Event Date 02/07/2018

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex with shield has not been returned for evaluation.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: ped2-475-18 mdrs related to this event: 2029214-2018-00120, 2029214-2018-00121, 2029214-2018-00122.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that a pipeline flex with shield did not open during a procedure.The patient was undergoing flow diversion treatment of an unruptured, amorphous aneurysm in the left internal carotid artery (ica).The aneurysm had a max.Diameter of 13.4mm and neck diameter of 3mm.The landing zone artery size was 4.73mm distal and 4.72mm proximal.Vessel tortuosity was described as moderate.A continuous heparinized saline flush was used during the procedure.A pipeline flex with shield was attempted to be placed.At deployment, it was reported that there was a delay in the distal end of the pipeline flex with shield braid opening.The device was resheathed and re-deployed; full opening of the braid was observed.However, during continued deployment of the braid, the device became stuck in the catheter.The pipeline flex with shield was unable to be pushed forward or pulled back.The braid slipped from its intended location and was subsequently removed with the catheter.Ultimately, the procedure was completed by aneurysm coiling.There were no reports of patient injury in association with this event.

Manufacturer Narrative

Device evaluation: the pipeline flex with shield was returned for evaluation.As received, the pipeline flex with shield was stuck at the distal segment of the catheter.The pipeline flex with shield could not be pushed forward or removed.For further examination, the catheter was cut to remove the pipeline flex with shield.The pipeline flex with shield distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.The pushwire appeared to be bent near the proximal end.The distal and proximal ends of the pipeline flex shield braid were found fully opened with moderate fraying.Based on the analysis findings, the report of pipeline flex with shield failure to open could not be confirmed ¿ the returned pipeline flex with shield braid were found fully open.It is possible that the patient¿s moderate vessel tortuosity contributed to the reported issues.Additionally, from the damage observed on the returned products, it appears that excessive force was used.It is likely the damage observed during analysis occurred when the pipeline flex devices were advanced/retrieved against resistance.Our instructions for use (ifu) provides the following guidance: ¿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.¿ 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: 7282953
• MDR Text Key: 100664884
• Report Number: 2029214-2018-00121
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/03/2020
• Device Model Number: PED-475-18
• Device Lot Number: A439489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2017
• 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: 52 YR