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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO XP PROVUE 4MM X 30MM; CATHETER, THROMBUS RETRIEVER
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STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO XP PROVUE 4MM X 30MM; CATHETER, THROMBUS RETRIEVER Back to Search Results
Model Number 90185
Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Patient Problems Embolus (1830); No Consequences Or Impact To Patient (2199)
Event Date 02/09/2020
Event Type  Injury  
Manufacturer Narrative
The subject device is unavailable to manufacturer.
 
Event Description
It was reported that during a thrombectomy procedure, the subject device retriever was done for right middle cerebral artery (mca-m2) and ent (embolization to new territory) was observed in right a1 segment.Ent was treated using the retriever and tici (thrombolysis in cerebral infaction) was achieved as grade 3.Approximately 5-7 days post the index procedure, the patient was discharged and the patient was assessed having a nihss (national institute of health stroke scale) of 1.
 
Manufacturer Narrative
Section b1 adverse event: remove adverse event.Section b2 outcomes attributed to ae: remove other serious (important medical events).Section h1 type of reportable event: remove serious injury.Based on additional information received from the site on 31-mar-2020 clarified that there was no adverse event (embolization to new territory).Since there was no adverse event and no reported malfunction of the device that could have caused or contributed to an adverse event, this event does not meet reporting criteria anymore and the reportability will be changed from reportable to non-reportable with new awareness date of on 31-mar-2020.Therefore, an assignable cause of undeterminable will be assigned to the ' device within specifications'.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
 
Event Description
It was reported that during a thrombectomy procedure, the subject device retriever was done for right middle cerebral artery (mca-m2) and ent (embolization to new territory) was observed in right a1 segment.Ent was treated using the retriever and tici (thrombolysis in cerebral infaction) was achieved as grade 3.Approximately 5-7 days post the index procedure, the patient was discharged and the patient was assessed having a nihss (national institute of health stroke scale) of 1.Update additional information: based on additional information received from the site on 31-mar-2020 clarified that there was no adverse event (embolization to new territory).Since there was no reported malfunction of the device that could have caused or contributed to the reported event, this event does not meet reporting criteria anymore and the reportability will be changed from reportable to non-reportable with the new awareness date of on 31-mar-2020.
 
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Brand Name
TREVO XP PROVUE 4MM X 30MM
Type of Device
CATHETER, THROMBUS RETRIEVER
Manufacturer (Section D)
STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY
4870 west 2100 south
salt lake city UT 84120
MDR Report Key9850302
MDR Text Key188842284
Report Number3012931345-2020-00043
Device Sequence Number1
Product Code NRY
UDI-Device Identifier00815742001853
UDI-Public00815742001853
Combination Product (y/n)N
PMA/PMN Number
K150616
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Remedial Action Inspection
Type of Report Initial,Followup
Report Date 04/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number90185
Device Catalogue Number90185
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received03/31/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
SYNCHRO 2 GUIDEWIRE (STRYKER); TREVO PR 18 MICROCATHETER (STRYKER)
Patient Outcome(s) Other;
Patient Age82 YR
Patient Weight77
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