MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO XP PROVUE 4MM X 20MM; CATHETER, THROMBUS RETRIEVER

Model Number	90182
Medical Device Problem Codes	Fracture (1260); Difficult to Remove (1528)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Ischemia Stroke (4418)
Date of Event	10/30/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient presented to the hospital with a clot on the superior division of the right middle cerebral artery (distal m1 segment).During the first attempt using the retriever, the subject retriever was stuck when the physician tried to pull it out and was noted to be broken.The physician was not able to remove all parts of the broken retriever.The detached part of the retriever was left in the right middle cerebral artery.The procedure was not completed successfully.Post procedure, the patient suffered from hemispheric stroke on the right.
Event or Problem Description
The patient presented to the hospital with a clot on the superior division of the right middle cerebral artery (distal m1 segment).During the first attempt using the retriever, the subject retriever was stuck when the physician tried to pull it out and was noted to be broken.The physician was not able to remove all parts of the broken retriever.The detached part of the retriever was left in the right middle cerebral artery.The procedure was not completed successfully.Post procedure, the patient suffered from hemispheric stroke on the right.
Additional Manufacturer Narrative
H3 device evaluated by mfg ¿updated.H3 summary attached - updated.Based on the results of the dhr review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.During visual inspection, the trevo retriever was returned with an xt-27 microcatheter and an unknown guidewire.The retriever pusher was returned, the distal end was found fractured and the shaped section was not attached to the core wire.The proximal coil was not attached to the core wire and was contained within the returned xt-27 microcatheter.The microcatheter was flushed and the proximal coil was removed, it was severely stretched.The xt-27 microcatheter was noted to be extensively deformed along its entire length and stretched to the distal end.Based on sem imaging of the device and reported "fracture" area, it was found that no fracture had occurred on the core wire itself.There was evidence of a separation of the device from at the msj (mid solder junction).A functional testing was unable to be performed due to the condition of the returned devices.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 device was returned and it was noted that the retriever shaped section had separated from the core wire, the retriever was unable to retrieved from the patient anatomy causing stroke.There was an xt-27 microcatheter returned with the device which was noted to be extensively deformed and stretched.It is likely that the microcatheter was damaged during the clinical procedure preventing the trevo retriever from being removed and the subsequent separation of the retriever during the attempt to retrieve.An assignable cause of procedural factors was assigned to the as reported issues difficult/unable to withdraw retriever, un-retrieved device fragments, retriever fracture/broken during use and patient stroke and to the analyzed issues retriever core wire broken during use and retriever coils damaged, 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.
Event or Problem Description
The patient presented to the hospital with a clot on the superior division of the right middle cerebral artery (distal m1 segment).During the first attempt using the retriever, the subject retriever was stuck when the physician tried to pull it out and was noted to be broken.The physician was not able to remove all parts of the broken retriever.The detached part of the retriever was left in the right middle cerebral artery.The procedure was not completed successfully.Post procedure, the patient suffered from hemispheric stroke on the right.
Additional Manufacturer Narrative
Based on the results of the dhr review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.During visual inspection, the trevo retriever was returned with an xt-27 microcatheter and an unknown guidewire.The retriever pusher was returned, the distal end was separated from the msj (mid solder junction), and the shaped section was not attached to the core wire.The proximal coil was not attached to the core wire.The proximal coil was noted to be contained within the returned xt-27 microcatheter.The microcatheter was flushed and the proximal coil was removed, it was severely starched and extensively deformed along its entire length to the distal end.Based on sem imaging of the device and reported "fracture" area, it was found that no fracture had occurred on the core wire itself.There was evidence of a separation of the device from at the msj (mid solder junction).During functional was unable to be performed due to the condition of the returned devices.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 device was returned and it was noted that the retriever shaped section had separated from the core wire, the retriever was unable to be retrieved from the patient causing stroke.There was an xt-27 microcatheter returned with the device which was noted to be extensively deformed and stretched.It is likely that the xt-27 microcatheter was damaged during the clinical procedure preventing the trevo retriever from being removed and the subsequent separation of the retriever during the attempt to retrieve.An assignable cause of procedural factors was assigned to the reported issues difficult/unable to withdraw retriever, un-retrieved device fragments, retriever fracture/broken during use and patient stroke and to the analyzed issues retriever fracture/broken during use and retriever coils damaged, 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 XP PROVUE 4MM X 20MM
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• MDR Report Key: 10925799
• Report Number: 3012931345-2020-00207
• Device Sequence Number: 1429643
• Product Code: NRY
• UDI-Device Identifier: 00815742001822
• UDI-Public: 00815742001822
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: K132641
• 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,Followup
• Report Date (Section B): 07/27/2021

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: 02/16/2021
• Device Model Number: 90182
• Device Catalogue Number: 90182
• Device Lot Number: 0000022639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Initial Date Received by Manufacturer: 11/04/2020
• Supplement Date Received by Manufacturer: 01/29/2021; 06/30/2021
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 02/25/2021; 07/28/2021
• 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: EXCELSIOR XT- 27 MICROCATHETER (STRYKER); EXCELSIOR XT- 27 MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Other