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

Model Number PED-500-16

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 03/17/2016

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex braid remains implanted in the patient.The delivery system was returned for evaluation.Evaluation is currently in progress; a follow up mdr will be submitted when evaluation is complete.

Event Description

Medtronic received report of pipeline flex hypotube detachment during a procedure.The patient was undergoing treatment for an unruptured, fusiform aneurysm.The aneurysm was located on the left side and spanned the internal carotid artery (ica) terminus to posterior communicating artery (pcom).Landing zone artery size was 2.58mm distal and 4.22mm proximal.The vessel was minimally tortuous.The devices were prepared as per ifu.The pipeline flex was deployed.The delivery system was removed with the ptfe wings pressed up against the distal tip of the catheter.Outside of the patient, the guide catheter was removed from the sheath and it was observed that the distal portion of the delivery system had detached at the hypotube; the detached section was found wedged in the distal end of the sheath.It was determined that the delivery system had detached when being pulled into the guide catheter, then became stuck in the sheath when the guide catheter was removed from the sheath.The pipeline flex was never resheathed.There was reportedly no resistance during removal of the delivery system.There was no report of patient injury as a result of this event.Angiographic result post-procedure was fine.

Manufacturer Narrative

Device evaluation the pipeline flex pushwire was returned for evaluation within the sheath.The guide catheter was not returned; therefore, any contributing factors from the guide catheter could not be assessed.As received, the distal segment (tip coil) of the pushwire was found to be partially deployed outside of the tip of the sheath.The remainder of the distal segment of the pushwire was found inside the sheath.The proximal segment of the pushwire was also found outside of the sheath.For further examination, the distal segment of the pushwire was pushed out the sheath.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 at a section near the proximal end.Based on the analysis findings and provided information, the report of pushwire detachment was confirmed; the received pushwire was found to be detached at the hypotube proximal to the wire weld.It is likely that the tensile overload exceeded the strength of the solder joint.Additionally, based on the damages seen on the distal coil (stretching), hypotube (stretching) and the proximal wire (bending), it appears that excessive force was used in this case, which subsequently caused the pushwire to become detached from the proximal wire weld.Per our instructions for use: ¿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.¿ 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.

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: 5569041
• MDR Text Key: 42380650
• Report Number: 2029214-2016-00215
• 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,Followup
• Report Date: 03/17/2016

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: 03/13/2018
• Device Model Number: PED-500-16
• Device Lot Number: A073790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2016
• Initial Date FDA Received: 04/12/2016
• Supplement Dates Manufacturer Received: Not provided; 03/17/2016
• Supplement Dates FDA Received: 05/12/2016; 09/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2015
• 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: 00037 YR