MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED-400-25

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Vasoconstriction (2126)

Event Date 11/21/2019

Event Type  Injury  

Manufacturer Narrative

The pipeline flex pushwire was returned stuck inside the marksman catheter.For further examination, the pipeline flex pushwire was then pushed out from the catheter lumen with difficulty.No pipeline flex braid was returned with the devices, as the braid was implanted in the patient.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 appeared to be stretched with the ptfe shrink tubing still intact.Bends were found at the proximal end of the pushwire.No damages were found with the 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 tip and marker were examined; and no damages were found.The catheter body found to be accordioned at the distal tip.No flash or voids molded were observed in the hub.The catheter was flushed with water and the water exited out from the distal tip.The catheter was then tested by running an in-house mandrel through catheter tip and hub.The mandrel successfully passed through the catheter hub and tip with no issues; however, the resistance observed at the damaged locations.Based on the analysis findings, the pipeline flex and marksman were confirmed to have resistance during delivery as the returned pipeline flex pushwire was stuck inside the marksman catheter.In addition, the pipeline flex pushwire and the marksman catheter were found to be damaged.From the damages seen on the catheter body (accordioning), pusher (bending) and hypotube (stretching); it appears there was high force used.It is likely these damages occurred when the customer attempted to advance the pipeline flex through the marksman catheter against resistance.It is likely that patient tortuous anatomy may have contributed to the resistance during delivery issues.Vasospasm is a known inherent risk of endovascular procedure and are documented in our device¿s instruction for use (ifu).Based on the reported information, there is no evidence suggesting that the device was defective, but rather a procedure related event.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during the embolization procedure, the patient experienced vasospasms.Nimodipine was administered for 10 minutes to treat the vasospasm.The procedure was completed via stent assisted coiling.The patient underwent embolization treatment for a small unruptured, saccular internal carotid artery aneurysm.Measuring 5.5 mm x 6 mm, landing zone distal 3.9 mm proximal 3.7 mm.The vessel anatomy was moderately tortuous.

• Brand Name: PIPELINE FLEX
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 9496801345
• MDR Report Key: 9686438
• MDR Text Key: 188892675
• Report Number: 2029214-2020-00126
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536015968
• UDI-Public: 00847536015968
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2022
• Device Model Number: PED-400-25
• Device Lot Number: A845199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2019
• 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 Outcome(s): Required Intervention
• Patient Age: 50 YR