MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO NXT 3MM X 32MM - US; NEUROVASCULAR MECHANICAL THROMBECTOMY DEVICE FOR ACUTE ISCHEMIC STROKE TREATMENT

Catalog Number	90312
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
Event or Problem Description
It was reported that during m2 thrombectomy, the operator attempted to deploy the subject retriever but met resistance.The operator removed the retriever and the microcatheter.No issues was seen on the imaging.A portion of the subject retriever was seen on the follow-up computed tomography (ct) scan done the next day.The subject retriever broke off and was left inside patient's anatomy.The impact to the patient is unknown.No further information is available.
Additional Manufacturer Narrative
Manufacturing date ¿ added expiration date - added there are controls in the manufacturing process to ensure the product met specifications upon release.Visual and functional inspections were not conducted due to the device was not returned.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.The reported event could not be confirmed and it cannot be confirmed that the device met specification, as the device was not returned.It was reported that the retriever broke off and was left in the patient.As per the additional information, the patient¿s anatomy was very tortuous and there was difficulty advancing the retriever up the microcatheter.There are a number of potential causes for the reported event, however, as the device was not returned and a review of all available information fails to indicate an assignable cause, an assignable cause of undeterminable will be assigned to the reported event.
Event or Problem Description
It was reported that during m2 thrombectomy, the operator attempted to deploy the subject retriever but met resistance.The operator removed the retriever and the microcatheter.No issues was seen on the imaging.A portion of the subject retriever was seen on the follow-up computed tomography (ct) scan done the next day.The subject retriever broke off and was left inside patient's anatomy.The impact to the patient is unknown.No further information is available.

• Brand Name: TREVO NXT 3MM X 32MM - 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
• 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: 17627033
• Report Number: 3012931345-2023-00198
• Device Sequence Number: 12648620
• Product Code: POL
• UDI-Device Identifier: 07613327299922
• UDI-Public: 07613327299922
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/15/2023

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: 01/02/2025
• Device Catalogue Number: 90312
• Device Lot Number: 0000211916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2023
• Supplement Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2023
• 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: 8 FRENCH SHEATH (UNKNOWN); MICROCATHETER (UNKNOWN)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 108 KG
• Patient Race: White