MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO XP PROVUE 6MM X 25MM; CATHETER, THROMBUS RETRIEVER

Model Number	90186
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Death (1802); Hemorrhage, Subarachnoid (1893); High Blood Pressure/ Hypertension (1908); Perforation of Vessels (2135); Device Embedded In Tissue or Plaque (3165)
Date of Event	02/29/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
Subject device not available.
Event or Problem Description
It was reported that a patient came with a stroke due to a thrombus in internal carotid artery, c1 segment and middle cerebral artery m1 right segment.Neurological assessment was national institutes of health stroke scale (nihss) of 15.Thrombectomy with the subject stent retriever was indicated with local anesthesia.During removal, the subject stent came off without resistance and remained in m1 vessel.Attempt to recover the stent with lasso failed and the ica siphon section was perforated.The patient suffered a major intracranial hypertension and sub arachnoid hemorrhage, was transferred to a neuro traumatic resuscitation unit, but passed away few hours post-procedure.No additional information is available at this time.
Additional Manufacturer Narrative
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 device was intended to be used for treatment.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 was received indicating repeated use of the lasso to try to retrieve the stent resulted in the vessel perforation and the reported patient intracranial hemorrhage and patient death.Based on the information provided, it is most likely that the trevo retriever stent became dislodged from the device itself due to anatomical or procedural factors encountered during the procedure, and the repeated use of the lasso to try to retrieve the stent resulted in the vessel perforation and the reported patient intracranial hemorrhage and patient death.An assignable cause of procedural factors will be assigned to the reported retriever fractured/broken during use, un-retrieved device fragments, patient vessel perforation, patient intracranial hemorrhage, and patient death as this issue 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.
Event or Problem Description
It was reported that a patient came with a stroke due to a thrombus in internal carotid artery, c1 segment and middle cerebral artery m1 right segment.Neurological assessment was national institutes of health stroke scale (nihss) of 15.Thrombectomy with the subject stent retriever was indicated with local anesthesia.During removal, the subject stent came off without resistance and remained in m1 vessel.Attempt to recover the stent with lasso failed and the ica siphon section was perforated.The patient suffered a major intracranial hypertension and sub arachnoid hemorrhage, was transferred to a neurotraumatic resuscitation unit, but passed away few hours post-procedure.No additional information is available at this time.
Event or Problem Description
It was reported that a patient came with a stroke due to a thrombus in internal carotid artery, c1 segment and middle cerebral artery m1 right segment.Neurological assessment was national institutes of health stroke scale (nihss) of 15.Thrombectomy with the subject stent retriever was indicated with local anesthesia.During removal, the subject stent came off without resistance and remained in m1 vessel.Attempt to recover the stent with lasso failed and the ica siphon section was perforated.The patient suffered a major intracranial hypertension and sub arachnoid hemorrhage, was transferred to a neurotraumatic resuscitation unit, but passed away few hours post-procedure.No additional information is available at this time.
Additional Manufacturer Narrative
D10: product available to stryker: updated.H3: device evaluated by mfg: updated.H3: summary attached: updated.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 product was returned and it was observed that the retriever section was not attached to the returned unit.The core wire and shaft coil were examined.The shaft coil was damaged ( kinked & stretched) and the core wire was broken.Performance testing was not performed due to the condition the device was received.From the condition of the product it appears that the product had been under excessive manipulation.The device was intended to be used for treatment.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 was received indicating repeated use of the lasso to try to retrieve the stent resulted in the vessel perforation and the reported patient intracranial hemorrhage and patient death.Based on the information provided, it is most likely that the trevo retriever stent became dislodged from the device itself due to anatomical or procedural factors encountered during the procedure, and the repeated use of the lasso to try to retrieve the stent resulted in the vessel perforation and the reported patient intracranial hemorrhage and patient death.An assignable cause of procedural factors will be assigned to the reported retriever fractured/broken during use, un-retrieved device fragments, patient vessel perforation, patient intracranial hemorrhage, and patient death as this issue 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.

• Brand Name: TREVO XP PROVUE 6MM X 25MM
• 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: 9826527
• Report Number: 3012931345-2020-00039
• Device Sequence Number: 3069027
• Product Code: NRY
• UDI-Device Identifier: 00815742001860
• UDI-Public: 00815742001860
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K143077
• 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): 06/11/2020

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 Expiration Date: 08/05/2021
• Device Model Number: 90186
• Device Catalogue Number: 90186
• Device Lot Number: 0000030930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 04/13/2020; 06/10/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 04/17/2020; 06/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Other; Required Intervention
• Patient Age: 80 YR