MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY; LASER THERAPY PRODUCT

Model Number PED2-500-35

Device Problems Material Deformation (2976); Activation Failure (3270); Physical Resistance/Sticking (4012)

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

Event Date 07/09/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a pipeline stent device that failed to open.When retrieving failed pipeline, it became stuck at the distal end of the phenom catheter.The patient was being treated for an unruptured 28mm fusiform aneurysm of the internal carotid artery.Vessel tortuosity was severe.It was reported that a navien intracranial support catheter was navigated to the aneurysm site.The phenom catheter and guide wire were then navigated to the distal neck of the aneurysm.The pipeline was delivered to the tip of the phenom microcatheter.However pipeline deployment failed.When trying to retrieve the pipeline, significant resistance was felt with the pipeline at the distal end of the phenom microcatheter so the devices were removed together.After pipeline deployment failure, use of a hyperform balloon was attempted but the balloon ruptured.The balloon was replaced with a non-medtronic balloon and afterward 4 pipeline stents were successfully placed to complete the procedure.All devices were prepared and catheters flushed per the instructions for use (ifu).There was no harm or injury to the patient.Post-op angio showed eclipse sign.

Manufacturer Narrative

H3: the pipeline flex w/shield embolization device (model: ped2-500-35 lot: b002406) and phenom 27 catheter (model: fg15150-0615-1s lot: ap19-080) were returned.The pushwire was protruding from the hub ~53.4cm and the tip coil and braid was partially deployed from catheter tip.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation.No bend was observed on the pushwire.The distal and proximal ends of the pipeline flex shield braid were found fully opened and moderately frayed.No defects were found with the tip coil, distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper.The total and usable lengths of the catheter were measured to be within specifications.The catheter body, tip and marker band were examined; no damages were found.No flash or voids molded were observed in the hub.The catheter was then tested by running an in-house 0.0265¿ mandrel through catheter tip and hub.The mandrel successfully passed through the catheter hub and tip without any issues.No other anomalies were observed.Based on the analysis findings, the pipeline flex and phenom 27 catheter could not be confirmed to have resistance during retrieval as no defect was found with the pipeline flex shield and phenom 27 catheter.In addition, based on the analysis findings, the pipeline flex shield was not confirmed to have failure to open.The event cause could not be determined as the returned pipeline flex shield braid was fully opened and moderately frayed.The damage to the braid on the ends of the pipeline flex shield is likely the results of the physician re-sheathing the device more than recommended two times.There was no non-conformance to specification identified that led to the failure to open issue.It is likely that the patient tortuous anatomy and damaged braid may have contributed to the reported issue.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• Type of Device: LASER THERAPY PRODUCT
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10267745
• MDR Text Key: 201544183
• Report Number: 2029214-2020-00686
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2023
• Device Model Number: PED2-500-35
• Device Catalogue Number: PED2-500-35
• Device Lot Number: B002406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Date Manufacturer Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1