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 Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Intracranial Hemorrhage (1891); Perforation of Vessels (2135); Vascular Dissection (3160)
Date of Event	09/17/2020
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 for the left p1 and basilar.Pre procedure, the patient neurological assessment showed a thrombolysis in cerebral infarction (tici) of 1, a national institute of health stroke scale (nihss) of 7, and mrs (modified rankin score) of 0.First, 1 pass for basilar was performed with subject device (retriever) and aspiration catheter.Next, pta (percutaneous transluminal angioplasty) was performed for basilar.Subsequently, thrombolytic therapy was performed for left p2, and finally, thrombectomy for left p1 was performed with subject device (retriever) and aspiration catheter.It was reported that there were vessel perforation/dissection and sah (subarachnoid hemorrhage) occurred during procedure which related to the subject device (retriever) and also occurrence of a removal difficulty of the subject device (retriever).The procedure was completed with thrombolysis in cerebral infarction score (tici) of 2b and nihss score of 40.It was unknown what medical treatment was administered to treat the patient¿s vessel dissection and sah.No further information is available.
Event or Problem Description
It was reported that thrombectomy procedure was performed for the left p1 and basilar.Pre procedure, the patient neurological assessment showed a thrombolysis in cerebral infarction (tici) of 1, a national institute of health stroke scale (nihss) of 7, and mrs (modified rankin score) of 0.First, 1 pass for basilar was performed with subject device (retriever) and aspiration catheter.Next, pta (percutaneous transluminal angioplasty) was performed for basilar.Subsequently, thrombolytic therapy was performed for left p2, and finally, thrombectomy for left p1 was performed with subject device (retriever) and aspiration catheter.It was reported that there were vessel perforation/dissection and sah (subarachnoid hemorrhage) occurred during procedure which related to the subject device (retriever) and also occurrence of a removal difficulty of the subject device (retriever).The procedure was completed with thrombolysis in cerebral infarction score (tici) of 2b and nihss score of 40.It was unknown what medical treatment was administered to treat the patient¿s vessel dissection and sah.No further information is available.
Additional Manufacturer Narrative
Although the dhr (device history record ) 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.Additional information provided by the customer indicated that the retriever was confirmed to be in good condition prior to use.According to the physician, dissection in the target lesion was suspected before deploying the stent and the trevo might have opened in the pseudo lumen.There was heavy resistance when removing the stent and then hemorrhage was observed.Based on the information provided, this complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural and/or anatomical factors during use.Therefore, an assignable cause of procedural factors will be assigned to the ar 'patient vessel perforation', 'patient vessel dissection', 'patient intracranial hemorrhage', and 'difficult/unable to withdraw retriever'.

• 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
• MDR Report Key: 10659848
• Report Number: 3012931345-2020-00155
• Device Sequence Number: 19625237
• Product Code: NRY
• UDI-Device Identifier: 00815742001853
• UDI-Public: 00815742001853
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 11/13/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 90185
• Device Catalogue Number: 90185
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/19/2020
• Supplement Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASPIRATION CATHETER (UNKNOWN MANUFACTURER).
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR