MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO XP PROVUE 4MM X 30MM; CATHETER, THROMBUS RETRIEVER

Model Number	90185
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Unclear Information (4052)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Speech Disorder (4415); Restenosis (4576); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is unavailable to manufacturer.
Event or Problem Description
It was reported that thrombectomy procedure was performed using the subject retrieval device to remove a clot in middle cerebral artery (mca) aneurysm at m1 segment.Prior procedure, the patient neurological assessment showed the thrombolysis in cerebral infarction (tici) of 1, national institute of health stroke scale (nihss) of 4 and mrs (modified rankin score) of 0.The technique used for this pass was considered successful.After the study procedure to 48 hours post procedure, the patient had neurological changes.Became aphasic with increased right sided weakness.Nihss went to 12 from a 1 at 24 hours post op.The patient went back to ct (computed tomography) scan and returned for another thrombectomy ¿ re occlusion of left m1 segment and found to have an area of stenosis.It was found another clot in left m2 segment.The physician did a thrombectomy on the clots and then returned to the stenosed area in m1 segment and placed a stent.Tici was 2b at 1224.The patient went back to icu on vent.A serial ct scan after the procedure revealed a subarachnoid hemorrhage with midline shift from 5 mm to 9 mm by the next morning.The patient had to go for an emergent decompressive craniectomy due to cerebral edema.The patient tolerated well and went back to icu for recovery.Today¿s ct scan shows resolution of the shift.The patient was discharged on day 5-7 with mrs (modified rankin score) of 5.Based on the physician¿s opinion that the adverse event was related to an index stroke, index procedure, pre-existing condition and the subject device.
Additional Manufacturer Narrative
Section d4 expiration date - added section d4 lot#- updated from unknown to lot # 0000041120 section h4 manufacturing date ¿ added.Based on the results of the dhr (device history record) review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.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.It was reported that after the study procedure to 48 hours post procedure, the patient's neurological changes became aphasic with increased right sided weakness.Thrombectomy was performed to treat the re-occlusion of left m1 by placing the stent to the stenosed area in m1.Additional information provided by the customer indicated that there was no malfunction reported for the device.The left m1 re-occlusion was related to pre-existing atherosclerosis and the left m2 clot was not related to any stryker devices.The reported 'patient vessel restenosis' and 'patient neurological deficit' 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.
Event or Problem Description
It was reported that thrombectomy procedure was performed using the subject retrieval device to remove a clot in middle cerebral artery (mca) aneurysm at m1 segment.Prior procedure, the patient neurological assessment showed the thrombolysis in cerebral infarction (tici) of 1, national institute of health stroke scale (nihss) of 4 and mrs (modified rankin score) of 0.The technique used for this pass was considered successful.After the study procedure to 48 hours post procedure, the patient had neurological changes.Became aphasic with increased right sided weakness.Nihss went to 12 from a 1 at 24 hours post op.The patient went back to ct (computed tomography) scan and returned for another thrombectomy ¿ re occlusion of left m1 segment and found to have an area of stenosis.It was found another clot in left m2 segment.The physician did a thrombectomy on the clots and then returned to the stenosed area in m1 segment and placed a stent.Tici was 2b at 1224.The patient went back to icu on vent.A serial ct scan after the procedure revealed a subarachnoid hemorrhage with midline shift from 5 mm to 9 mm by the next morning.The patient had to go for an emergent decompressive craniectomy due to cerebral edema.The patient tolerated well and went back to icu for recovery.Today¿s ct scan shows resolution of the shift.The patient was discharged on day 5-7 with mrs (modified rankin score) of 5.Based on the physician¿s opinion that the adverse event was related to an index stroke, index procedure, pre-existing condition and the subject device.
Additional Manufacturer Narrative
B1 product problem: corrected: no adverse event.B2 outcomes attributed to ae : corrected : no outcomes attributed to ae.B5 executive summary: updated.H1 type of reportable event: corrected : no serious injury.Device code grid : corrected: unclear information.Conclusion code grid: corrected - cause not established.F10 / h6 health effect - clinical code: corrected : no health consequences or impact.F10 / h6 health effect - impact code: corrected: no clinical signs, symptoms or conditions.Based on additional information received on 21-april-2022 from the site indicated that the adverse event (restenosis of left m1, clot in left m2) was unrelated to the index procedure or stryker device.Therefore, this event does not meet reporting criteria anymore and the reportability will be changed from reportable to non-reportable with a new awareness date of 21-april-2022.While there are a number of potential causes for the reported issue, because the reported issue is unclear and the device was not returned, an assignable cause of undeterminable was assigned to this complaint.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 or Problem Description
It was reported that thrombectomy procedure was performed using the subject retrieval device to remove a clot in middle cerebral artery (mca) aneurysm at m1 segment.Prior procedure, the patient neurological assessment showed the thrombolysis in cerebral infarction (tici) of 1, national institute of health stroke scale (nihss) of 4 and mrs (modified rankin score) of 0.The technique used for this pass was considered successful.After the study procedure to 48 hours post procedure, the patient had neurological changes.Became aphasic with increased right sided weakness.Nihss went to 12 from a 1 at 24 hours post op.The patient went back to ct (computed tomography) scan and returned for another thrombectomy re-occlusion of left m1 segment and found to have an area of stenosis.It was found another clot in left m2 segment.The physician did a thrombectomy on the clots and then returned to the stenosed area in m1 segment and placed a stent.Tici was 2b at 1224.The patient went back to icu on vent.A serial ct scan after the procedure revealed a subarachnoid hemorrhage with midline shift from 5 mm to 9 mm by the next morning.The patient had to go for an emergent decompressive craniectomy due to cerebral edema.The patient tolerated well and went back to icu for recovery.Today¿s ct scan shows resolution of the shift.The patient was discharged on day 5-7 with mrs (modified rankin score) of 5.Based on the physician¿s opinion that the adverse event was related to an index stroke, index procedure, pre-existing condition and the subject device.Update: based on additional information received on 21-april-2022 from the site indicated that the adverse event (restenosis of left m1, clot in left m2) was unrelated to the index procedure or stryker device.Therefore, this event does not meet reporting criteria anymore and the reportability will be changed from reportable to non-reportable with a new awareness date of 21-april-2022.

• Brand Name: TREVO XP PROVUE 4MM X 30MM
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer (Section G): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 10558897
• Report Number: 3012931345-2020-00144
• Device Sequence Number: 19509912
• Product Code: NRY
• UDI-Device Identifier: 00815742001853
• UDI-Public: 00815742001853
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K150616
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/16/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/15/2022
• Device Model Number: 90185
• Device Catalogue Number: 90185
• Device Lot Number: 0000041120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/27/2020
• Supplement Date Received by Manufacturer: 12/22/2020; 04/21/2022
• Initial Report FDA Received Date: 09/21/2020
• Supplement Report FDA Received Date: 01/12/2021; 05/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AXS CATALYST 6 DISTAL ACCESS CATHETER (STRYKER).; AXS INFINITY LONG SHEATH CATHETER (STRYKER).; PENUMBRA PUMP.; SYNCHRO 2 GUIDEWIRE (STRYKER).; AXS CATALYST 6 DISTAL ACCESS CATHETER (STRYKER); AXS INFINITY LONG SHEATH CATHETER (STRYKER); PENUMBRA PUMP; SYNCHRO 2 GUIDEWIRE (STRYKER)
• Outcome Attributed to Adverse Event: Disability; Required Intervention; Other
• Patient Age: 37 YR
• Patient Sex: Female