MAUDE Adverse Event Report: COVIDIEN, IRVINE PIPELINE FLEX W/SHIELD TECHNOLOGY; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED2-400-20

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 08/15/2017

Event Type  malfunction  

Manufacturer Narrative

The reported product remains implanted in patient; therefore, product analysis could not be performed.As a result, the cause of the clinical observation could not be conclusively determined.The pipeline instructions for use advise, ¿"choose a pipeline¿ flex shield embolization device with labeled diameter that approximates the target vessel diameter.¿ select an appropriately sized pipeline¿ flex shield embolization device such that its fully expanded diameter is equivalent to that of the largest target vessel.An incorrectly sized pipeline¿ flex shield embolization device may result in inadequate device placement, incomplete opening, or migration.¿ the pipeline¿ flex shield embolization device foreshortens substantially (50-60%) during deployment.Take device foreshortening into account when deploying the pipeline¿ flex shield embolization device.".

Event Description

Medtronic received information that the pipeline shield device reportedly migrated after it was deployed to treat a 3cm unruptured, clipped, neck remnant aneurysm in the internal carotid artery (ica).This patient was reported to have moderate vessel tortuosity.The device was prepared following the instructions for use (ifu) and the device was implanted in the intended location with full wall apposition.After deployment, the physician reportedly "massaged" the pipeline shield device, and it suddenly foreshortened to become approximately 10mm in length.Another flow diverter was placed distally for this patient.No injury resulted.Angiographic result post procedure was good.

Manufacturer Narrative

Additional information device remains implanted in patient.Therefore device analysis could not be performed.The actual cause of the clinical observation could not be determined with available information.However, procedural photographs were provided.Based on the photos provided by the reporter, the reported "braid foreshortening" and migration after deployment" issue was confirmed.It could be possible that when the microcatheter passed through the stent during catheter and delivery wire removal, the implanted braid (pipeline flex with shield technology) was bumped "massaged as reported".The patient's moderate vessel tortuosity could also be a contributing factor.Per pipeline flex with shield technology instruction for use, "after the entire pipeline flex embolization device is deployed, advance the microcatheter through the device making sure not to dislodge the braid.When the microcatheter tip is distal to the pipeline flex embolization device, retract the delivery wire into the micro catheter tip.Do no attempt to re-position the pipeline flex embolization device with shield technology after deployment past the resheathing marker.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.¿ if information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

This report was submitted with the date of report as the manufacture notified date.A correction is being filed to reflect the date of report as the date the initial report was submitted.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• 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 ; 9496821224
• MDR Report Key: 6862273
• MDR Text Key: 86006231
• Report Number: 2029214-2017-01031
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: EXPORT ONLY
• 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,Followup
• Report Date: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2019
• Device Model Number: PED2-400-20
• Device Lot Number: A368269
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/31/2016
• 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