MAUDE Adverse Event Report: CONCENTRIC MEDICAL TREVO PROVUE; CATHETER, THROMBUS RETRIEVER

Catalog Number	90184
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the thrombectomy procedure to treat the occluded m1 segment of the middle cerebral artery (mca), the retriever(subject device) could not be withdrawn.Following unsuccessful attempt to remove the clot with the concomitant microcatheter, the physician elected the use of non-stryker device to aspirate the thrombus and completed the procedure.No further information is available.
Event or Problem Description
It was reported that during the thrombectomy procedure to treat the occluded m1 segment of the middle cerebral artery (mca), the retriever(subject device) could not be withdrawn.Following unsuccessful attempt to remove the clot with the concomitant microcatheter, the physician elected the use of non-stryker device to aspirate the thrombus and completed the procedure.No further information is available.
Additional Manufacturer Narrative
D4 expiration date ¿ added d10 product available to stryker ¿ updated d10 returned to manufacturer on ¿updated h3 device evaluated by mfg ¿updated h3 summary attached - updated h4 manufacturing date ¿ added the device history record confirms that the device met all material, assembly and performance specifications.Visual inspection was performed on the returned sample and there were no anomalies were observed.Functional testing revealed that device was successfully advanced through the demo insertion tool and through the demo microcatheter without any difficulties.Information provided by the customer indicated that no anomalies were noted to the device after removal from the packaging or prior to preparation, the device was prepared as per the dfu (direction for use), continuous flush was maintained throughout the procedure, the retriever was not torqued, and no additional force was applied to overcome resistance in the vessel when withdrawing the device.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.While it is possible that the patient's anatomy may have contributed to the reported event, this could not be definitively determined based on available information.Therefore a cause of not confirmed has been assigned to this investigation.

• Brand Name: TREVO PROVUE
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): CONCENTRIC MEDICAL; 301 east evelyn; mountain view CA 94041
• MDR Report Key: 8617791
• Report Number: 0002954917-2019-00003
• Device Sequence Number: 3030854
• Product Code: NRY
• UDI-Device Identifier: 00815742001846
• UDI-Public: 00815742001846
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K133464
• 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): 07/03/2019

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: 10/28/2019
• Device Catalogue Number: 90184
• Device Lot Number: 62952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 07/03/2019
• 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: TREVO® PRO 18 MICROCATHETER(STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR