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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO PROVUE 4MM X 20MM; CATHETER, THROMBUS RETRIEVER
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STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO PROVUE 4MM X 20MM; CATHETER, THROMBUS RETRIEVER Back to Search Results
Model Number 90184
Device Problem Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/27/2020
Event Type  malfunction  
Event Description
It was reported that during an acute occlusion case where there was thrombus at the middle cerebral artery (mca) the stent retriever (subject device) was stuck and could not be pulled back to be removed from the vessel.The physician used already in use microcatheter to withdraw the subject retriever into the catheter and remove it from the patient¿s anatomy.The procedure was completed successfully.There were no clinical consequences to the patient.
 
Manufacturer Narrative
H4 manufacturing date added.H3 device evaluated by mfg updated.H3 summary attached updated.D4 expiration date added.D10 product available to stryker updated.D10 returned to manufacturer on updated.The device was returned and the lot number was confirmed with the packaging returned with the device.During visual inspection, the subject retriever was returned inserted in a non-stryker catheter.The catheter distal shaft was severely flattened.The retriever could not be advanced or pulled back through the catheter so the catheter was cut in an attempt to remove the retriever.It was found severely damaged.The catheter wrinkled at the hub section when trying to advance and retract the retriever.A functional test was unable to be performed due to the damage noted to the device.Based on the results of the dhr review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.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.The reported complaint was confirmed based on analysis and event description.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information received from the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and continuous flush was maintained throughout the clinical procedure.There was some damage noted to the retriever shaped section.It is probable that the device sustained some damage as a result of the difficulty to withdraw the retriever.An assignable cause of procedural factors will be assigned to the reported/as analyzed 'difficult/unable to withdraw retriever' and to the analyzed 'retriever shaped section damage' as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
 
Event Description
It was reported that during an acute occlusion case where there was thrombus at the middle cerebral artery (mca) the stent retriever (subject device) was stuck and could not be pulled back to be removed from the vessel.The physician used already in use microcatheter to withdraw the subject retriever into the catheter and remove it from the patient¿s anatomy.The procedure was completed successfully.There were no clinical consequences to the patient.
 
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Brand Name
TREVO PROVUE 4MM X 20MM
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 Key11208314
MDR Text Key228005475
Report Number3012931345-2021-00015
Device Sequence Number1
Product Code NRY
UDI-Device Identifier00815742001846
UDI-Public00815742001846
Combination Product (y/n)N
PMA/PMN Number
K132641
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 03/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/05/2021
Device Model Number90184
Device Catalogue Number90184
Device Lot Number0000026497
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/14/2021
Initial Date Manufacturer Received 12/28/2020
Initial Date FDA Received01/21/2021
Supplement Dates Manufacturer Received03/03/2021
Supplement Dates FDA Received03/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
REBAR18 MICROCATHETER (MEDTRONIC).; REBAR18 MICROCATHETER (MEDTRONIC)
Patient Age91 YR
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