MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 SUPPORT GUIDECATHETER; CATHETER, PERCUTANEOUS

Model Number RFX058-125-08

Device Problem Material Perforation (2205)

Patient Problem Fistula (1862)

Event Date 07/04/2019

Event Type  Injury  

Manufacturer Narrative

The navien catheter has not been returned for evaluation; therefore, product analysis cannot be performed.The device was not returned; therefore, the reported event could not be confirmed.The cause of the event cannot be conclusively determined from the provided information.Related mdrs for this event: 2029214-2019-00747.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that pipeline flex device did not open during the procedure and vessel was damage when navien catheter moved in a different direction from the direction of blood stream.The patient was undergoing embolization treatment with flow diversion for a medium unruptured saccular left internal carotid (ic) cavernous aneurysm, measuring 15mmx5mm, landing zone distal 3.3mm proximal 3.8mm.The vessel was observed severely tortuous.It was reported that a case of flow diverter with a 15 mm-sized aneurysm on the inner side of the curve of an ic-cave omega shaped blood vessel.The roadmaster 8 fr was placed in the ic, and the navien 5fr 125 cm was placed in the curve in front of the aneurysm.Preparation was performed according to the instructions per the ifu, marksman via the traxcess wire was delivered to the m1.Reported pipeline was prepared according to the instructions per the ifu, and pipeline was delivered within the marksman and it was delivered to the tip portion.As recommended, the sleeve was removed with marksman (the first time of re-sheath), it was pulled down to the target lesion with a ¿system pull¿ , and deployment was attempted with wire push.However, it did not deploy at all from the tip portion of the pipeline.Even though it deployed to mid part of the pipeline did not expand at all.Even system pull / system push was performed for several times, the deployment was failed.Therefore, as repositioning, a full re-sheath (the second time) was performed once with marksman.And then it delivered to the straight-line part near the ic-top, and an attempt was made to expand the pipeline distal flare.Even wire push / wire pull / system push / system was performed, the pipeline did not expand at all and it never started to expand even at the mid site.The vascular tortuosity of the lesion site was severe, navien could only advance to the front of the aneurysm.In order to improve the operability, and in order to deliver navien to the distal side of the aneurysm, it was planned to the replace wire in marksman from traxcess to chikai 18 wire to enhance backup.However, there was no preparation of the distributor and thus it was changed to chikai 14 wire, and it was attempted to raise navien to the distal side of the aneurysm.However, the angle was tight like a hairpin curve, and navien could not be delivered further distally from the tortuosity part of the proximal region of the aneurysm.At that time, it was suspected that the navien 5 fr 125 was pushed up slightly strong, and navien moved in a different direction from the direction of blood stream.When it was checked by angiography, the blood vessel was injured at the tortuosity part ic of the proximal region of the aneurysm, and hemorrhage (ccf) was caused.There was no choice, the pipeline was deployed again while keeping navien in the proximal region of the aneurysm, but it was not deployed at all and abnormality with the product was felt, and the pipeline was decided to be collected.When the implant part of the pipeline was checked, it was found that thrombus adhered to the distal flare and the tip was deflated, and the braid slightly came apart.After that, a new pipeline was unpacked, and it was deployed smoothly.As ccf was developed, one more pipeline was implanted additionally, and ccf was caused, but the pipeline implantation procedure was successfully completed.In the aneurysm, the eclipse sign appeared clearly, but hemorrhage of the ccf was not settled.The ccf hemorrhage site will be followed up and the procedure was completed temporarily.Right after the treatment, the patient's condition did not deteriorate.The worst situation was escaped extracranially.Next week, follow-up observation was planned to be performed by angiography.No dapt performed.

• Brand Name: SUPPORT GUIDECATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• 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 ; 7635263305
• MDR Report Key: 8794646
• MDR Text Key: 151179437
• Report Number: 2029214-2019-00748
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K110055
• 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
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2021
• Device Model Number: RFX058-125-08
• Device Lot Number: A766040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/04/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/13/2019
• 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; Disability
• Patient Age: 80 YR