MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO NXT 4MM X 41MM - US; NEUROVASCULAR MECHANICAL THROMBECTOMY DEVICE FOR ACUTE ISCHEMIC STROKE TREATMENT

Model Number	90314
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/25/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
During thrombectomy procedure, the subject retriever was used to remove blood clot from the left mca (middle cerebral artery) m1 segment.Prior procedure, the patient neurological assessment showed the nihss (national institute of health stroke scale) score of 18 and mrs (modified ranquin scale) of 0.It was reported that during retrieval of second pass at ica (internal carotid artery) terminus, the subject retriever broke inside patient¿s vessel possibly weakened junction after first pass and the resistance encountered during advancement.The physician tried to remove the fractured subject retriever with a snare device, but it was unsuccessful.Therefore, the fractured subject retriever was retained in vasculature.The procedure was completed with a new retriever device (non-stryker) with third pass and the clot was successfully removed and restored the blood flow.The aspirin and clopidogrel were provided to the patient from carotid stent.The patient has no experienced or complication due to the retrieved fragment.The patient was discharged to rehab and assessed having a nihss of 2 and mrs of 2.
Event or Problem Description
During thrombectomy procedure, the subject retriever was used to remove blood clot from the left mca (middle cerebral artery) m1 segment.Prior procedure, the patient neurological assessment showed the nihss (national institute of health stroke scale) score of 18 and mrs (modified ranquin scale) of 0.It was reported that during retrieval of second pass at ica (internal carotid artery) terminus, the subject retriever broke inside patient¿s vessel possibly weakened junction after first pass and the resistance encountered during advancement.The physician tried to remove the fractured subject retriever with a snare device, but it was unsuccessful.Therefore, the fractured subject retriever was retained in vasculature.The procedure was completed with a new retriever device (non-stryker) with third pass and the clot was successfully removed and restored the blood flow.The aspirin and clopidogrel were provided to the patient from carotid stent.The patient has no experienced or complication due to the retrieved fragment.The patient was discharged to rehab and assessed having a nihss of 2 and mrs of 2.
Additional Manufacturer Narrative
D4 expiration date - added h4 manufacturing date ¿ added h3 device evaluated by mfg-h3 summary attached - updated the device history record review confirms that there is no indication that the device, labeling or packaging failed to meet its specifications when released.A subject trevo nxt retriever core wire was returned without stent and introducer tool/sheath.During analysis, the returned device was visually inspected the damage to the pebax portion (that cover the distal portion of the trevo nxt corewire) was seen at the fracture region.Permanent set at distal end of wire (bend to approximately 90 degrees over ~5 cm).Severe (~90 degree) kink/bend just proximal to fracture site in direction of thinner side of pebax jacket.The functional testing could not be performed due to the condition of the returned device.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.This complaint appears to be associated with a product that met stryker and design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to 'procedural factors' during use.Therefore an assignable cause of 'procedural factors' will be assigned to the as reported issue and investigation.

• Brand Name: TREVO NXT 4MM X 41MM - US
• Common Device Name: NEUROVASCULAR MECHANICAL THROMBECTOMY DEVICE FOR ACUTE ISCHEMIC STROKE TREATMENT
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• MDR Report Key: 10709062
• Report Number: 3012931345-2020-00159
• Device Sequence Number: 3933747
• Product Code: POL
• UDI-Device Identifier: 07613327299946
• UDI-Public: 07613327299946
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K200117
• 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): 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/13/2022
• Device Model Number: 90314
• Device Catalogue Number: 90314
• Device Lot Number: 0000045346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Initial Date Received by Manufacturer: 09/28/2020
• Supplement Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 02/11/2021
• 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: BALLOON GUIDE CATHETER (STRYKER); MEDTRONIC SOLITAIRE STENT RETRIEVER; PENUMBRA ACE CATHETER; BALLOON GUIDE CATHETER (STRYKER); MEDTRONIC SOLITAIRE STENT RETRIEVER; PENUMBRA ACE CATHETER
• Outcome Attributed to Adverse Event: Other; Required Intervention; Disability
• Patient Age: 38 YR