MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 CATHERA; CATHETER, CONTINUOUS FLUSH

Model Number FG15150-0615-1S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fistula (1862); Intracranial Hemorrhage (1891)

Event Date 01/29/2020

Event Type  Injury  

Manufacturer Narrative

Since the device was not returned, we are unable to perform further root cause analysis and the exact cause of the reported event is unknown.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.No corrective action.Monitoring and trending this type of event.Vessel damage and hemorrhage are known inherent risks of endovascular procedure and are documented in our device¿s instruction for use (ifu).Linked with mdr: 2029214-2020-00100.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that the postoperative angiography revealed bleeding from the internal carotid artery c4 part (cabanas) to the vein and a carotid-cavernous fistula (ccf) occurred.The patient underwent treatment of a left, internal carotid artery (ica) c4, saccular aneurysm.The aneurysm was unruptured.The max diameter was 11 mm and the neck was 6 mm.The distal landing zone was 3.7 mm and the proximal was 4 mm.The vessel anatomy was normal to moderate.Pipeline placement was planned for the reported aneurysm.As twisting occurred on the proximal side of the aneurysm, when attempting to release the twist with a system push, phenom27 injured the internal carotid artery, and excessive force was applied towards the vein direction, then, bleeding and ccf were caused.Although an attempt was made to stop bleeding with hyperform 7*7, but it failed.The 6f envoy was placed on the vein side, and hemostasis was performed for cabanas sinus with targetxl3-8, 4-12 × 4, 5-15 × 2, primeframe4-15.It was judged that there was no health damage to the patient even after the anesthesia was awake.The devices were prepared and used per the instructions for use (ifu).The catheter was flushed as per the ifu.

• Brand Name: CATHERA
• Type of Device: CATHETER, CONTINUOUS FLUSH
• 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: 9678731
• MDR Text Key: 188889714
• Report Number: 2029214-2020-00107
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K151638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FG15150-0615-1S
• Device Lot Number: AP19-032
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/29/2020
• Initial Date FDA Received: 02/06/2020
• Was Device Evaluated by Manufacturer?: No
• 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: 47 YR