MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR PIPELINE FLEX; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED-375-25

Device Problems Physical Resistance (2578); Activation Failure (3270)

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

Event Date 05/19/2018

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation; therefore, the cause of the event could not be determined.Correspondence has been sent out for the return of the device.Once the device has been received and the evaluation completed, a supplemental report will be submitted.Reference: mdr# 2029214-2018-00590.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that two pairs of medtronic microcatheters and medtronic flow diverters both experienced large resistance when approximately 5mm of each tip coil of the flow diverters were outside past the microcatheter distal tips.A continuous he parinized saline flush was maintained during the procedure.Prior to the two events, the first microcatheter was advanced and placed in the m3 and they attempted to deliver the flow diverter; however, large resistance was experienced when approximately 5mm of the tip coil was outside the distal tip of the microcatheter.Due to failed additional attempts to deliver the flow diverter against the resistance, a guide catheter was advanced to the ophthalmic segment and the microcatheter and flow diverter was exchanged out for a new medtronic microcatheter and a new medtronic flow diverter (3.75 x 25).The new flow diverter (3.75 x 25) was attempted to be deployed and, once again, large resistance was experienced when the distal tip coil was approximately 5mm past the distal tip of the microcatheter.This flow diverter (3.75 x 25) also could not be deployed despite several additional attempts.In both instances, the physician did loosen the load (slack) in the system to try to resolve the issue but without success.Both flow diverters experience the large resistance in the distal parts of the microcatheters.It was also noted that both pipelines had difficulty opening in the distal segments.The devices were removed from the patient.Both of the distal segments of the microcatheter were found to be folded and damaged.Spring coils and stent were selected to complete the procedure.No patient injury was reported as a result of the procedure.Post procedural angiography showed level 3 blood flow in the patient.The patient was undergoing embolization treatment of an unruptured saccular aneurysm measuring 8mm x 5mm located in the ophthalmic segment of the right internal carotid artery (ica).It was unknown if dual antiplatelet therapy was administered.The distal and proximal landing zone was 3.2mm x 3.9mm.The patient¿s vasculature was severe in tortuosity and the access vessel (femoral) was 5mm in diameter.The flow diverters were not used off label and those two flow diverters, along with the ancillary devices, were prepared as indicated in the instructions for use.There were no damages observed on the pushwires of the flow diverters or on the microcatheters prior to use.Ancillary devices: 7f cook90 sheath.

Manufacturer Narrative

Additional information clarifying the reported event.There should have been no report of the pipeline failing to open as only 5mm of the pipeline's tip coil (total length of tip coil = 15mm) was outside of the catheter.The large resistance encountered by the pipeline caused it never to come out of the marksman microcatheter distal tip; therefore, the physician did not have a chance to attempt to open the pipeline.The event should not have been not-reportable.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The pipeline flex delivery system stuck inside the distal segment of the marksman catheter was returned for evaluation and the delivery system could not be pushed forward or removed.The catheter was cut to remove the pipeline flex delivery system.The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.The distal and proximal ends of the pipeline flex braid were found fully opened and moderately frayed.The pushwire appeared to be bent near the proximal end.The catheter body was found to be accordioned near the distal tip.The catheter was then tested by running an in-house mandrel through catheter tip and hub.The mandrel could pass through the catheter tip and hub with no issue; however, resistance was observed at the accordioned locations.The product analysis does not suggest a potential or confirm manufacturing issue; therefore, no lot history record review is require d.Based on the analysis findings, the event descriptions, the customer reports of resistance were confirmed as the received pipeline flex delivery system was found to be stuck within distal segment of the marksman catheter.The returned pipeline flex and the marksman catheter were found to be damaged.The customer reported that the patient¿s vessel tortuosity was severe.In addition, the devices were prepared per the ifu and a continuous flush was maintained during delivery.It is possible that the ¿severe vessel tortuosity¿ may have contributed to the resistance during delivery.From the damages seen on the catheter body (accordioning), pipeline flex braid (fraying), proximal wire (bending) and hypotube (stretching); it appears there was high force used (pushing and pulling).It is likely these damages occurred when the customer attempted to advance/retrieve the pipeline flex delivery system through the micro catheter against the reported resistance.In this event, the user context may have contributed as the customer continued to advance the pipeline flex delivery system despite high resistance.The event should not have been reportable.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE FLEX
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9492753836
• MDR Report Key: 7653696
• MDR Text Key: 112849836
• Report Number: 2029214-2018-00591
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P100018.S011
• 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: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/06/2020
• Device Model Number: PED-375-25
• Device Lot Number: A566574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2017
• 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: 53 YR