MAUDE Adverse Event Report: TREVO PRO 18 MICROCATHETER 157CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	90238
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	12/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is 1 of 2 reports.The subject device is unavailable to manufacturer.
Event or Problem Description
During thrombectomy procedure, the subject device microcatheter (trevo pro microcatheter) and other devices were used to remove the proximal face of clot located at the right ica (internal carotid artery)- intracranial-t (bifurcation) extending to m1 and m2.Prior procedure, the patient neurological assessment showed the tici (thrombolysis in cerebral infarction score) of 0.It was reported that the vessel perforation occurred during manipulation.There were no symptomatic intracranial hemorrhage (sich) or neurological deterioration reported.The event was resolved without medical treatment to the patient.24 hours post procedure, the patient neurological assessment showed (tici) of 3 and nihss of 18.According to the site, the relationship of the vessel perforation to the subject device microcatheter and to the procedure.No other information was provided.
Additional Manufacturer Narrative
Section b5 executive summary: updated.Section f1/h6 health impact code grid: corrected.This is 1 of 2 reports.
Event or Problem Description
During thrombectomy procedure, the subject device microcatheter (trevo pro microcatheter) and other devices were used to remove the proximal face of clot located at the right ica (internal carotid artery)- intracranial-t (bifurcation) extending to m1 and m2.Prior procedure, the patient neurological assessment showed the tici (thrombolysis in cerebral infarction score) of 0.It was reported that the vessel perforation occurred during manipulation.There were no symptomatic intracranial hemorrhage (sich) or neurological deterioration reported.The event was resolved without medical treatment to the patient.24 hours post procedure, the patient neurological assessment showed (tici) of 3 and nihss of 18.According to the site, the relationship of the vessel perforation to the subject device microcatheter and to the procedure.No other information was provided.Update information: received additional information on 8-january-2021 stated that the cause of vessel perforation was microwire perforation when passing through area of vasospasm.The physician waited for 2 minutes, there was no clinical deterioration and after a repeat angiogram, the contrast extravasation did not expand.The patient¿s vessel perforation was resolved without treatment.However, it was reported that the patient has died six days later after post procedure due to aspiration pneumonia gcs 8; with onset day 48h or more post-procedure.
Event or Problem Description
During thrombectomy procedure, the subject device microcatheter (trevo pro microcatheter) and other devices were used to remove the proximal face of clot located at the right ica (internal carotid artery)- intracranial-t (bifurcation) extending to m1 and m2.Prior procedure, the patient neurological assessment showed the tici (thrombolysis in cerebral infarction score) of 0.It was reported that the vessel perforation occurred during manipulation.There were no symptomatic intracranial hemorrhage (sich) or neurological deterioration reported.The event was resolved without medical treatment to the patient.24 hours post procedure, the patient neurological assessment showed (tici) of 3 and nihss of 18.According to the site, the relationship of the vessel perforation to the subject device microcatheter and to the procedure.No other information was provided.Update information: received additional information on 8-january-2021 stated that the cause of vessel perforation was microwire perforation when passing through area of vasospasm.The physician waited for 2 minutes, there was no clinical deterioration and after a repeat angiogram, the contrast extravasation did not expand.The patient¿s vessel perforation was resolved without treatment.However, it was reported that the patient has died six days later after post procedure due to aspiration pneumonia gcs 8; with onset day 48h or more post-procedure.
Additional Manufacturer Narrative
Although the dhr could not be reviewed because the lot number of the (subject device) trevo pro microcatheter remains unknown, there are controls in the manufacturing process to ensure the product met specifications upon release.The (subject device) trevo pro microcatheter 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 vessel perforation occurred during manipulation involving the (subject device) trevo microcatheter.Additional information provided by the customer indicated that the synchro2 and (subject device) trevo pro 18 mc performed as intended, the tortuosity of the patient's anatomy was moderate, and continuous flush was maintained during the procedure.In the physician's opinion, the cause of vessel perforation was due to microwire perforation when passing through an area of vasospasm.The reported 'patient vessel perforation' 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 was assigned to this event.This is 1 of 2 reports.

• Brand Name: TREVO PRO 18 MICROCATHETER 157CM
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 11121898
• Report Number: 3012931345-2021-00003
• Device Sequence Number: 845838
• Product Code: DQO
• UDI-Device Identifier: 00815742002386
• UDI-Public: 00815742002386
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K113260
• 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): 02/11/2021

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
• Operator of Device: Health Professional
• Device Model Number: 90238
• Device Catalogue Number: 90238
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/14/2020
• Supplement Date Received by Manufacturer: 01/08/2021; 02/03/2021
• Initial Report FDA Received Date: 01/06/2021
• Supplement Report FDA Received Date: 01/31/2021; 02/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 7 DISTAL ACCESS CATHETER (STRYKER); AXS INFINITY LONG SHEATH CATHETER (STRYKER); MEDELA DOMINANT FLEX PUMP (STRYKER); SYNCHRO 14 GUIDEWIRE (STRYKER); TREVO NXT PROVUE 3 (STRYKER); TREVO PRO 18 MICROCATHETER (STRYKER); AXS CATALYST 7 DISTAL ACCESS CATHETER (STRYKER); AXS INFINITY LONG SHEATH CATHETER (STRYKER); MEDELA DOMINANT FLEX PUMP (STRYKER); SYNCHRO 14 GUIDEWIRE (STRYKER); TREVO NXT PROVUE 3 (STRYKER); TREVO PRO 18 MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 83 YR