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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 3MM X 20MM; CATHETER, THROMBUS RETRIEVER
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STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO XP PROVUE 3MM X 20MM; CATHETER, THROMBUS RETRIEVER Back to Search Results
Catalog Number 90183
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 12/10/2019
Event Type  Injury  
Manufacturer Narrative
The subject device is unavailable to manufacturer.
 
Event Description
It was reported that during treatment of the occluded in m2 left segment, an emboli to new territory (ent) had occurred in left a2 segment.It is unknown if there was medical intervention performed to treat the patient¿s ent.Neurological assessment showed pre-procedure a national institute of health stroke scale (nihss) score of 15 and 24 hours post procedure nihss score of 11.No other information was provided.
 
Manufacturer Narrative
Section b2: outcomes attributed to ae: added "required intervention to prevent permanent impaired/damage (devices).
 
Event Description
It was reported that during treatment of the occluded in m2 left segment, an emboli to new territory (ent) had occurred in left a2 segment.It is unknown if there was medical intervention performed to treat the patient¿s ent.Neurological assessment showed pre-procedure a national institute of health stroke scale (nihss) score of 15 and 24 hours post procedure nihss score of 11.No other information was provided.Update additional information; received additional information on 12-feb-2020 stated that the ent (embolization to new territory) was removed by using direct aspiration.Post procedure the patient tici (thrombolysis in cerebral infarction) score achieved grade3 and national institute of health stroke scale (nihss) score improved after 24 hours post procedure.However, the subarachnoid hemorrhage (sah) occurred after 48 hours and pneumonia after one week and both conditions have been resolved.The site indicated that the (sah) was related to index stroke and unrelated to procedure or preexisting condition or the device.The pneumonia was related to index stroke and pre-existing condition and was not related to procedure or the device.
 
Event Description
It was reported that during treatment of the occluded in m2 left segment, an emboli to new territory (ent) had occurred in left a2 segment.It is unknown if there was medical intervention performed to treat the patient¿s ent.Neurological assessment showed pre-procedure a national institute of health stroke scale (nihss) score of 15 and 24 hours post procedure nihss score of 11.No other information was provided.Update additional information; received additional information on 12-feb-2020 stated that the ent (embolization to new territory) was removed by using direct aspiration.Post procedure the patient tici (thrombolysis in cerebral infarction) score achieved grade3 and national institute of health stroke scale (nihss) score improved after 24 hours post procedure.However, the subarachnoid hemorrhage (sah) occurred after 48 hours and pneumonia after one week and both conditions have been resolved.The site indicated that the (sah) was related to index stroke and unrelated to procedure or preexisting condition or the device.The pneumonia was related to index stroke and pre-existing condition and was not related to procedure or the device.
 
Manufacturer Narrative
Section b5- updated additional information: received additional information on 12-feb-2020 stated that the ent (embolization to new territory) was removed by using direct aspiration.Post procedure the patient tici (thrombolysis in cerebral infarction) score achieved grade3 and national institute of health stroke scale (nihss) score improved after 24 hours post procedure.However, the subarachnoid hemorrhage (sah) occurred after 48 hours and pneumonia after one week and both conditions have been resolved.The site indicated that the (sah) was related to index stroke and unrelated to procedure or preexisting condition or the device.The pneumonia was related to index stroke and pre-existing condition and was not related to procedure or the device.Section d : catalog # search: corrected : the catalog # has been updated to "90183" gtin # had been updated.Section g: pma/510(k)#; corrected : the 510k # has been updated to "k133464".Although the 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 the technique used was successful, no technical issues were reported, and the ent was removed using direct aspiration.The patient's tici score achieved grade 3 and nihss score improved after 24 hrs post procedure.The reported 'patient embolus' is a known and anticipated complication to these types of procedures and patient condition and is listed as such in the device directions for use.Therefore, a probable cause of anticipated procedural complication will be assigned to this event.
 
Event Description
It was reported that during treatment of the occluded in m2 left segment, an emboli to new territory (ent) had occurred in left a2 segment.It is unknown if there was medical intervention performed to treat the patient¿s ent.Neurological assessment showed pre-procedure a national institute of health stroke scale (nihss) score of 15 and 24 hours post procedure nihss score of 11.No other information was provided.Update additional information; received additional information on 12-feb-2020 stated that the ent (embolization to new territory) was removed by using direct aspiration.Post procedure the patient tici (thrombolysis in cerebral infarction) score achieved grade3 and national institute of health stroke scale (nihss) score improved after 24 hours post procedure.However, the subarachnoid hemorrhage (sah) occurred after 48 hours and pneumonia after one week and both conditions have been resolved.The site indicated that the (sah) was related to index stroke and unrelated to procedure or preexisting condition or the device.The pneumonia was related to index stroke and pre-existing condition and was not related to procedure or the device.Update additional information #2: based on additional information received from the site on 2-mar-2020 confirmed that a3 occlusion was present at the baseline and 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 (b)(6) 2020.In addition, the device did not cause or contribute to any adverse event.Nor was it related to a malfunction or deterioration in the characteristics or performance of the device or labeling issues.
 
Manufacturer Narrative
Section b1: adverse event/product problem: corrected to no adverse event.Section b2: outcomes attributed to ae : corrected to no other serious.Section b5: executive summary :updated.Based on additional information received from the site on 2-mar-2020 confirmed that a3 occlusion was present at the baseline and 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 (b)(6) 2020.In addition, the device did not cause or contribute to any adverse event.Nor was it related to a malfunction or deterioration in the characteristics or performance of the device or labeling issues.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
 
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Brand Name
TREVO XP PROVUE 3MM 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 Key9640074
MDR Text Key183761942
Report Number3012931345-2020-00015
Device Sequence Number1
Product Code NRY
Combination Product (y/n)N
PMA/PMN Number
K133464
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup,Followup
Report Date 03/13/2020
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 Number90183
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/20/2020
Initial Date FDA Received01/28/2020
Supplement Dates Manufacturer Received02/14/2020
02/14/2020
03/02/2020
Supplement Dates FDA Received02/24/2020
02/24/2020
03/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
3MAX (PENUMBRA); CATALYST 6 (STRYKER)
Patient Outcome(s) Other; Required Intervention;
Patient Age76 YR
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