MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO SELECT-14 SUPPORT ST 215CM; GUIDE, WIRE, CATHETER, NEUROVASCULATURE

Catalog Number	SSUP215STR
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the acute ischemic stroke (ais) right m1 procedure when attempting to cross a lesion with the subject guidewire, the hard clot required multiple attempts, resulting in a approximately 5cm of the distal tip of the subject guidewire to break off and remain in the patients anatomy.Efforts were made to retrieve the fragment, but it could not be removed, resulting in a 120 minutes surgical delay.Recanalization could not be obtained, therefore the procedure was not completed.The residual fragment had no impact on the patient.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that during the acute ischemic stroke (ais) right m1 procedure when attempting to cross a lesion with the subject guidewire, the hard clot required multiple attempts, resulting in a approximately 5cm of the distal tip of the subject guidewire to break off and remain in the patients anatomy.Efforts were made to retrieve the fragment, but it could not be removed, resulting in a 120 minutes surgical delay.Recanalization could not be obtained, therefore the procedure was not completed.The residual fragment had no impact on the patient.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.Analysis of the returned device found only 208cm of the subject guidewire proximal fragment was returned.Approximately 15cm of the distal fragment was not returned.The nitinol tubing of the proximal fragment was broken/fractured.The core wire and platinum coil were not visible inside the broken proximal fragment.The damage to the returned device indicates it encountered a significant force during use.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 event was confirmed based on the damage noted to the returned device.The device failed to meet specification when returned for analysis.Additional information provided by the customer did not indicate any issues noted during unpacking or set up of the device, and the device was prepared as per dfu instructions.There was no indication of a user related issue.The anatomy was reported to be average tortuous.The guidewire was shaped 120 degrees.There was the introducer sheath used, when inserting the guidewire.Flush was given inside the microcatheter at the time when the guidewire was inserted and there was no friction or resistance felt at the hub.There was no friction or resistance while the guidewire was advancing in the microcatheter.The device was used for an acute ischemic stroke (ais) (right m1) medical procedure.An assignable cause of procedural factors will be assigned to the as reported guidewire distal tip broken/fractured during use, un-retrieved device fragments, device difficulty engaging target vessel and as analysed guidewire distal tip broken/fractured during use, un-retrieved device fragments 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: SYNCHRO SELECT-14 SUPPORT ST 215CM
• Common Device Name: GUIDE, WIRE, CATHETER, NEUROVASCULATURE
• 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: 19792240
• Report Number: 3012931345-2024-00132
• Device Sequence Number: 7114116
• Product Code: MOF
• UDI-Device Identifier: 07613327508611
• UDI-Public: 07613327508611
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K202522
• 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): 09/10/2024

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: 08/30/2026
• Device Catalogue Number: SSUP215STR
• Device Lot Number: 0000554442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/01/2024
• Supplement Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2023
• 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: EMBOTRAP (CERENOVUS, JOHNSON & JOHNSON); GOOSENECK SNARE (MEDTRONIC); SOLITAIRE (MEDTRONIC); TREVO (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown