MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO NXT 6MM X 37MM - US; NEUROVASCULAR MECHANICAL THROMBECTOMY DEVICE FOR ACUTE ISCHEMIC STROKE TREATMENT

Catalog Number	90315
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the middle cerebral artery infarction procedure, physician deployed the subject stent retriever at the proximal of m1.While attempting to withdrawing the subject stent retriever together with the microcatheter, resistance was encountered.The subject stent retriever was fractured from the delivery wire.The fractured part of the subject stent retriever was left within the patient anatomy.The physician has the opinion that one of the reasons was that there was severe tortuosity that the vessels near the internal carotid artery - top were tortuous and the aspiration catheter was not able to raise up.The patient is hospitalized.
Additional Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
Event or Problem Description
It was reported that during the middle cerebral artery infarction procedure, physician deployed the subject stent retriever at the proximal of m1.While attempting to withdrawing the subject stent retriever together with the microcatheter, resistance was encountered.The subject stent retriever was fractured from the delivery wire.The fractured part of the subject stent retriever was left within the patient anatomy.The physician has the opinion that one of the reasons was that there was severe tortuosity that the vessels near the internal carotid artery - top were tortuous and the aspiration catheter was not able to raise up.The patient is hospitalized.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿ updated.H3 summary attached - updated.D4 expiration date - added.D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿ updated.There are controls in the manufacturing process to ensure the product met specifications upon release.During visual/microscopic inspection, the retriever core wire was noted to be broken/fractured with stretching noted to the pebax jacket at approximately 198 cm from the proximal end.The pebax was removed and there was some evidence of trauma and necking noted to the fracture point.The retriever shaped section was not returned.The insertion tool was not returned.Functional inspection was not carried out due to the damage noted to the 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.The reported events can be confirmed based on the device analysis.The device failed to meet specification, based on the damage noted to the device.It was reported that after the subject retriever was deployed from the proximal m1, and when an attempt was made to retrieve it together with microcatheter, strong resistance was encountered.When they were kept retrieving, it was noticed that the retriever was fractured from the delivery wire because resistance was no longer felt.The fractured retriever is remained in the body.The surgeon has the opinion that one of the reasons was that there was severe tortuosity that the vessels near the ic-top were tortuous, and the aspiration catheter was not able to raise up.In addition, since she was using aspiration catheter, she did not want to retract stent retriever into aspiration catheter to avoid damaging on the aspiration catheter, so she pulled stent retriever alone.As per the additional information, the patient¿s anatomy was described as severely tortuous.The retriever did pass through any stented arteries.The device was returned, and the core wire was noted to be fractured with stretching noted to the pebax jacket and trauma and necking noted the retriever core wire fracture point, the damage noted is indicative of excessive tension forces being applied to the device during removal, which aligns with the reported events.It is probable that the patients severely tortuous anatomy may have caused or contributed to the reported difficulty to withdraw the retriever and the subsequent retriever fracture.An assignable cause of ¿procedural factors¿ will be assigned to the as reported ¿retriever fracture/ broken during use¿ and ¿difficult/unable to withdraw retriever¿ and ¿un-retrieved device fragments¿ and the as analyzed ¿retriever core wire broken during use¿ and ¿retriever delivery wire lamination issue¿, as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.

• Brand Name: TREVO NXT 6MM X 37MM - 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: 18989548
• Report Number: 3012931345-2024-00049
• Device Sequence Number: 20885090
• Product Code: POL
• UDI-Device Identifier: 07613327299953
• UDI-Public: 07613327299953
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 05/15/2024

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: 12/06/2024
• Device Catalogue Number: 90315
• Device Lot Number: 206225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/01/2024
• Supplement Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 03/27/2024
• Supplement Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2022
• 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: SOFIA ASPIRATION CATHETER (MICROVENTION); TREVO TRAK 21 MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown