MAUDE Adverse Event Report: CONCENTRIC MEDICAL UNKNOWN_NEUROVASCULAR_PRODUCT; CATHETER, PERCUTANEOUS

Catalog Number UNK_NEU

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

Patient Problem Embolus (1830)

Event Date 06/24/2019

Event Type  Injury  

Manufacturer Narrative

This is 2 of 2 reports.The subject device is unavailable to manufacturer.

Event Description

It was reported that during treatment of the occluded in m1 segment of the middle cerebral artery (mca), the patient had a distal emboli in the internal carotid artery (ica).No adverse event associated with the distal emboli was reported.No further information is available.

Manufacturer Narrative

Additional information received from the site on 28-october-2019 clarified that the adverse event (embolization to new territory) is not related to the trevo and balloon catheter devices.The site also reported that there were multiple clots present at baseline m1, m2, icat (internal carotid artery terminus) bifurcation and the patient died four days later after procedure due to respiratory failure.The site has confirmed that the ent and subsequent event of death were not related to procedure or stryker devices, but related to the pre-existing medical conditions.In addition, the devices did not cause or contribute to the reported event.Nor were they related to a malfunction or deterioration in the characteristics or performance of the devices or labeling issues.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the subject device.This is 2 of 2 reports.

Event Description

It was reported that during treatment of the occluded in m1 segment of the middle cerebral artery (mca), the patient had a distal emboli in the internal carotid artery (ica).No adverse event associated with the distal emboli was reported.No further information is available.Update additional information: additional information received from the site on 28-october-2019 clarified that the adverse event (embolization to new territory) is not related to the trevo and balloon catheter devices.The site also reported that there were multiple clots present at baseline m1, m2, icat (internal carotid artery terminus) bifurcation and the patient died four days later after procedure due to respiratory failure.The site has confirmed that the ent and subsequent event of death were not related to procedure or stryker devices, but related to the pre-existing medical conditions.In addition, the devices did not cause or contribute to the reported event.Nor were they related to a malfunction or deterioration in the characteristics or performance of the devices or labeling issues.

• Brand Name: UNKNOWN_NEUROVASCULAR_PRODUCT
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CONCENTRIC MEDICAL; 301 east evelyn; mountain view CA 94041
• MDR Report Key: 9208556
• MDR Text Key: 163126613
• Report Number: 0002954917-2019-00011
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K153729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup
• Report Date: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_NEU
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TREVO XP PROVUE RETRIEVER (STRYKER)
• Patient Outcome(s): Other
• Patient Age: 74 YR