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

Model Number 90182

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Intracranial Hemorrhage (1891); No Consequences Or Impact To Patient (2199)

Event Date 11/19/2019

Event Type  Injury  

Manufacturer Narrative

Although the dhr could not be reviewed because the lot number remains unknown, there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not returned.Therefore, visual and functional analysis were not performed.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.Additional information provided by the customer indicated that the event occurred due to pre-existing condition.The trevo device performed as intended.The reported 'patient intracranial hemorrhage' is a known and anticipated complication to these types of procedures and patient condition and is listed as such in the device directions for use.Therefore, a probable cause of anticipated procedural complication will be assigned to this event.Device discarded at hospital.

Event Description

It was reported that after a successful thrombectomy procedure performed at the basilar artery, intracranial hemorrhage was observed inside the patient¿s anatomy within 24 hours after the procedure.The subject retriever was used during the procedure.In the physician¿s opinion, the subject retriever performed as intended during the procedure and the reported adverse event was related to patient¿s pre-existing condition.No additional clinical consequences were reported to the patient.

Event Description

It was reported that after a successful thrombectomy procedure performed at the basilar artery, intracranial hemorrhage was observed inside the patient¿s anatomy within 24 hours after the procedure.The subject retriever was used during the procedure.In the physician¿s opinion, the subject retriever performed as intended during the procedure and the reported adverse event was related to patient¿s pre-existing condition.No additional clinical consequences were reported to the patient.Additional information was received on 11 mar 2020: there was no adverse event following the procedure.No additional clinical consequences were reported to the patient.

Manufacturer Narrative

Section b1 : adverse event/product problem: corrected to no adverse event/product problem: section b2: outcomes attributed to ae: corrected to no other serious.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device was not returned; therefore, physical as well as a functional evaluation could not be performed.The reported complaint could not be confirmed and it could not be definitively determined if the device failed to meet specifications because the product was not returned.Information received on 11-mar-2020 clarified that that there was no adverse event (intercranial hemorrhage).Since there was no reported malfunction of the device that could have caused or contributed to the reported event, this event does not meet reporting criteria anymore and the reportability will be changed from reportable to non-reportable with the new awareness date of on 11-mar-2020.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.In conclusion, the device did not cause or contribute to any adverse event.Nor was it related to a malfunction or deterioration in the characteristics or performance of the device or labeling issues.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

• Brand Name: TREVO XP PROVUE 4MM X 20MM
• Type of Device: CATHETER, THROMBUS RETREIVER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• MDR Report Key: 9795440
• MDR Text Key: 183128412
• Report Number: 3012931345-2020-00035
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815742001822
• UDI-Public: 00815742001822
• Combination Product (y/n): N
• PMA/PMN Number: K132641
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/02/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: 90182
• Device Catalogue Number: 90182
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/10/2020
• Initial Date FDA Received: 03/05/2020
• Supplement Dates Manufacturer Received: 03/11/2020
• Supplement Dates FDA Received: 04/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MARKSMAN27 CATHETER (COVIDIEN)
• Patient Outcome(s): Other
• Patient Age: 83 YR