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	03/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during procedure cat 7 catheter, marksman (medtronic microcatheter), (b)(4) (asahi intec.Guidewire) were used to place a microcatheter into m1 and advanced cat 7 catheter.However, because of severe meandering anatomy, the product was worn out, thus a new cat 7 + phenom 27 (medtronic microcatheter) + (b)(4) were used.No allegations against cat 7 catheter.Cat 7 catheter could not be advanced much, but phenom 27 microcatheter could be advanced to the periphery, so the stent (subject device) was deployed from there.At this time, the stent (subject device) deployed normally, and there was no feeling of any stuck nor resistance.The stent (subject device) was inserted into the phenom 27 microcatheter and was able to advance to the lesion without any particular resistance, so it was unsheathed there.Leaving the stent (subject device) in place, an attempt was made to remove the phenom 27 microcatheter, hoping that by removing the phenom 27 microcatheter, cat 7 catheter would be advanced, and removed the phenom 27 microcatheter as usual.When phenom 27 microcatheter was removed as usual without any resistance, there was no wire that was supposed to come out, and when it was checked, it was found that the stent (subject device) had not been deformed and the delivery wire was coming out from the proximal end of the microcatheter that was removed, and when the delivery wire we removed from the microcatheter and checked, there was no stent, only the delivery wire was retrieved.A cbct (cone-beam computed tomography systems) was then taken, and it was confirmed that the stent (subject device) was in place in the deployed position.Retrieval with a snare was considered but no snare was used, at this point, the procedure was completed with the stent in place which was supposed to be retrieved, considering that the patient was in the same condition as when he was admitted (not recanalized, but no bleeding or other problems had occurred).
Event or Problem Description
It was reported that during procedure cat 7 catheter, marksman (medtronic microcatheter), chikai-14 200cm (asahi intec.Guidewire) were used to place a microcatheter into m1 and advanced cat 7 catheter.However, because of severe meandering anatomy, the product was worn out, thus a new cat 7 + phenom 27 (medtronic microcatheter) + chikai-14 200cm were used.No allegations against cat 7 catheter.Cat 7 catheter could not be advanced much, but phenom 27 microcatheter could be advanced to the periphery, so the stent (subject device) was deployed from there.At this time, the stent (subject device) deployed normally, and there was no feeling of any stuck nor resistance.The stent (subject device) was inserted into the phenom 27 microcatheter and was able to advance to the lesion without any particular resistance, so it was unsheathed there.Leaving the stent (subject device) in place, an attempt was made to remove the phenom 27 microcatheter, hoping that by removing the phenom 27 microcatheter, cat 7 catheter would be advanced, and removed the phenom 27 microcatheter as usual.When phenom 27 microcatheter was removed as usual without any resistance, there was no wire that was supposed to come out, and when it was checked, it was found that the stent (subject device) had not been deformed and the delivery wire was coming out from the proximal end of the microcatheter that was removed, and when the delivery wire we removed from the microcatheter and checked, there was no stent, only the delivery wire was retrieved.A cbct (cone-beam computed tomography systems) was then taken, and it was confirmed that the stent (subject device) was in place in the deployed position.Retrieval with a snare was considered but no snare was used, at this point, the procedure was completed with the stent in place which was supposed to be retrieved, considering that the patient was in the same condition as when he was admitted (not recanalized, but no bleeding or other problems had occurred).
Additional Manufacturer Narrative
Based on the results of the dhr (device history review) review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.During visual inspection, the core wire was fractured 199.8cm from prox of core wire and the retriever shaped section was not returned as it remains in the patient.The device was returned with a non-stryker catheter and there was blood on the hub.The non-stryker catheter was found to be damaged.A functional test was not required as the fracture was confirmed.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 was returned, and it was confirmed that the retriever core wire was fractured proximal to the stent portion of the retriever.Additional information and images provided by customer confirmed the stent portion of the retriever was left in the patient anatomy.Based on the condition of the returned devices and the provided images, the subject device may have fractured due to the severe meandering anatomy.It is probable that there were procedural and/or anatomical factors present during the clinical procedure which caused the event.An assignable cause of 'procedural factors' will be assigned to the as reported ¿un-retrieved device fragments¿ and the as reported/as analyzed code 'retriever core wire broken during use', 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 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
• 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: 14061949
• Report Number: 3012931345-2022-00077
• Device Sequence Number: 4614743
• Product Code: POL
• UDI-Device Identifier: 07613327299946
• UDI-Public: 07613327299946
• 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): 06/24/2022

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: 11/02/2022
• Device Model Number: 90314
• Device Catalogue Number: 90314
• Device Lot Number: 0000054051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2022
• Supplement Date Received by Manufacturer: 06/23/2022
• Initial Report FDA Received Date: 04/08/2022
• Supplement Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2020
• 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: CAT 7 CATHETER (STRYKER).; CHIKAI 14 200CM (ASAHI INTEC. GUIDEWIRE).; MARKSMAN (MEDTRONIC MICROCATHETER).; PHENOM 27 (MEDTRONIC MICROCATHETER).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female