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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN_NEUROVASCULAR_PRODUCT; CATHETER, INTRAVASCULAR, DIAGNOSTIC
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UNKNOWN_NEUROVASCULAR_PRODUCT; CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Catalog Number UNK_NEU
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Perforation of Vessels (2135); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/04/2020
Event Type  Injury  
Manufacturer Narrative
This is 2 of 2 reports.The subject device is unavailable to manufacturer.
 
Event Description
It was reported that the subject device microcatheter trevo trak 21 along with other devices were used to remove a clot located at the right middle cerebral artery (mca) m1 segment.During the first pass navigation through a small branch of mca distally from thrombosis, the vessel injury/perforation was occurred in the right mca territory.The navigation o to truncus inferior not possible, consecutively proximal.There was no symptomatic sah (subarachnoid hemorrhage) occurred during procedure or neurological deterioration.The event was resolved without medical treatment to the patient.24 hours post procedure, the patient neurological assessment showed thrombolysis in cerebral infarction score (tici) of 3.According to the physician, the event is related to the index procedure and the subject device microcatheter trevo trak 21.No other information was provided.
 
Manufacturer Narrative
Section a patient information: updated (gender: male / age: 36 years/ weight: 90kg/ not hispanic or latino, white section e initial reporter name: updated from unknown to dr.Tsogkas although the device history record (dhr) could not be reviewed because the lot number remains unknown, there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.Additional information provided by the customer indicated that no issues were encountered during use of the trevo trak 21 that led to the patient's vessel injury and sah and the physician felt the subject device performed as intended.The patient's vessel injury and sah were resolved without any treatment required and the patient has completely recovered with no neurological symptoms.The reported 'patient vessel perforation' and 'patient hemorrhage, blood loss without sequelae' are known and anticipated complications to these types of procedures and patient condition and are listed as such in the device directions for use.Therefore, an assignable cause of anticipated procedural complication will be assigned to this event.This is 2 of 2 reports.
 
Event Description
It was reported that the subject device microcatheter trevo trak 21 along with other devices were used to remove a clot located at the right middle cerebral artery (mca) m1 segment.During the first pass navigation through a small branch of mca distally from thrombosis, the vessel injury/perforation was occurred in the right mca territory.The navigation o to truncus inferior not possible, consecutively proximal.There was no symptomatic sah (subarachnoid hemorrhage) occurred during procedure or neurological deterioration.The event was resolved without medical treatment to the patient.24 hours post procedure, the patient neurological assessment showed thrombolysis in cerebral infarction score (tici) of 3.According to the physician, the event is related to the index procedure and the subject device microcatheter trevo trak 21.No other information was provided.
 
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Brand Name
UNKNOWN_NEUROVASCULAR_PRODUCT
Type of Device
CATHETER, INTRAVASCULAR, DIAGNOSTIC
MDR Report Key10954445
MDR Text Key219872382
Report Number3012931345-2020-00214
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
PMA/PMN Number
K192122
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 01/29/2021
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 NumberUNK_NEU
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/11/2020
Initial Date FDA Received12/05/2020
Supplement Dates Manufacturer Received01/08/2021
Supplement Dates FDA Received01/29/2021
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 Number1
Treatment
SYNCHRO2 GUIDEWIRE (STRYKER)
Patient Outcome(s) Other;
Patient Age36 YR
Patient Weight90
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