MAUDE Adverse Event Report: CONCENTRIC MEDICAL TREVO PRO 18RO MICROCATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 90238

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

Patient Problems Death (1802); Hemorrhage, Cerebral (1889)

Event Date 04/28/2015

Event Type  Death  

Event Description

It was reported that the patient underwent uneventful mechanical thrombectomy procedure using the retrieval device and the microcatheter (subject device) to treat a m1 middle cerebral artery occlusion.However, after the procedure, the patient suffered a reperfusion hemorrhage and the same day the patient died.The physician stated that the patient's death was not related to the devices and it was unknown if there was any relationship between the death and the procedure.

Event Description

It was reported that the patient underwent uneventful mechanical thrombectomy procedure using the retrieval device and the microcatheter (subject device) to treat a m1 middle cerebral artery occlusion.However, after the procedure, the patient suffered a reperfusion hemorrhage and the same day the patient died.The physician stated that the patient's death was not related to the devices and it was unknown if there was any relationship between the death and the procedure.

Manufacturer Narrative

The device is not available to the manufacturer.

Manufacturer Narrative

Initially it was reported that the trevo pro 18 microcatheter was used for the procedure; however, new information was received that a velocity.025 catheter manufactured by penumbra was used with the trevo retriever device.Manufacturer has reviewed all information and determined that as the device was not manufactured by the reporting manufacturer, this event no longer meets the requirement of the reportable event for the device in question.

• Brand Name: TREVO PRO 18RO MICROCATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CONCENTRIC MEDICAL; 301 east evelyn; mountain view CA 94041
• Manufacturer (Section G): CONCENTRIC MEDICAL; 301 east evelyn; mountain view CA 94041
• Manufacturer Contact: kathleen shin ; 301 east evelyn; mountain view, CA 94041 ; 6509382100
• MDR Report Key: 4789582
• MDR Text Key: 5877586
• Report Number: 0002954917-2015-00029
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113260
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/29/2015

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 Catalogue Number: 90238
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2015
• Initial Date FDA Received: 05/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: MODIFIED TREVO XP PROVUE RETRIEVER (CONCENTRIC)
• Patient Outcome(s): Death
• Patient Age: 98 YR