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

Model Number PED-475-14

Device Problems Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

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

Event Date 01/28/2016

Event Type  malfunction  

Manufacturer Narrative

This medical device report is being resubmitted to the emdr system due to a connection error within the emdr system.The event was previously reported to the emdr portal and an acknowledgement 3 received, but the connection error prevented the emdr system from documenting the report.The report number in this report is the same number as the impacted report that has the connection issue.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report of pipeline flex push wire break during a procedure.The patient was being treated for an unruptured, saccular aneurysm in the left ophthalmic internal carotid artery (ica).Max diameter was 6mm and neck diameter was 4mm.Landing zone artery size was 3.8mm distal and 4.4 mm proximal.The vessel tortuosity was normal.The devices were prepared and used as per ifu.The pipeline flex was delivered to the distal end of the catheter with a normal amount of resistance.The pipeline flex was partially unsheathed and the physician decided to reposition it.The physician attempted to resheath, but the push wire (which was still within the catheter) broke in the distal section.This occurred during the first re-sheathing attempt.The system (pipeline flex and catheter) was removed from the patient together.The pipeline flex will be returned for evaluation.There was no report of injury as a result of this event.See pe 701216519 for the post-procedure event.

Manufacturer Narrative

Manufacturer narrative - additional information, device evaluation: the pipeline flex was returned for evaluation.As received, the distal segment of the delivery system and a segment of the braid were found partially deployed outside of the catheter tip.The remainder of the pipeline flex was found inside the catheter lumen.For further examination, the pipeline flex delivery system was pushed out the catheter.The tip coil appeared to be stretched near the distal dps restraint.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 in one section.The pipeline flex braid was found to be fully open with damage on the distal end.Based on the reported event details and analysis findings, the report of pipeline flex pushwire separation was confirmed.It is likely that the tensile overload exceeded the strength of the solder joint.It is possible that the reported resistance during delivery may have contributed to the reported issues.The damage on the returned devices indicate that the devices were likely advanced and pulled against the resistance causing the delivery system to become bent, stretched and detached at the hypotube proximal to the wire weld.However, the cause for resistance could not be conclusively determined.It should be noted that pipeline flex instructions for use 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.¿ the lot history record of the 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.

• 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: 5527693
• MDR Text Key: 149357693
• Report Number: 2029214-2016-00091
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536016651
• UDI-Public: 00847536016651
• 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: 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2018
• Device Model Number: PED-475-14
• Device Catalogue Number: PED-475-14
• Device Lot Number: A146895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2016
• Initial Date FDA Received: 03/25/2016
• Supplement Dates Manufacturer Received: 03/01/2016
• Supplement Dates FDA Received: 03/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2015
• 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 Age: 66 YR