MAUDE Adverse Event Report: CONCENTRIC MEDICAL TREVO XP PROVUE RETRIEVER 4X20; CATHETER, THROMBUS RETRIEVER

Catalog Number	90182
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage, Cerebral (1889)
Date of Event	03/22/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available.
Event or Problem Description
It was reported that the patient underwent successful mechanical thrombectomy of the left m2 middle cerebral artery (mca) occlusion with the subject retrieval device.One pass was made with the retrieval device and aspiration was used two times.The patient had a thrombolysis in cerebral ischemia score of 3 after treatment.However, after the index procedure, the patient suffered a symptomatic intracranial hemorrhage.No treatment was required and the outcome was reported as resolved.Fourteen days post procedure, the patient was discharged to general hospital for short terms.The event were reported to be related to the procedure and unknown if related to the device.
Additional Manufacturer Narrative
Correction - lot # was changed from 83538 to unknown.During investigation it was found that the reported lot number 83538 could not be found in the manufacturing database likely because it is not the correct device lot number.Therefore, review of the manufacturing records, including relevant device history records (dhr) of the trevo xp provue retriever 4x20 catalog number 90182 could not be performed.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.From the information provided there was no indication that the device was not used as in accordance with the labeling or that this caused or contributed to the reported event however, hemorrhage is a known risks associated with endovascular procedures and are listed as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complications was assigned to this event.
Event or Problem Description
It was reported that the patient underwent successful mechanical thrombectomy of the left m2 middle cerebral artery (mca) occlusion with the subject retrieval device.One pass was made with the retrieval device and aspiration was used two times.The patient had a thrombolysis in cerebral ischemia score of 3 after treatment.However, after the index procedure, the patient suffered a symptomatic intracranial hemorrhage.No treatment was required and the outcome was reported as resolved.Fourteen days post procedure, the patient was discharged to general hospital for short terms.The event were reported to be related to the procedure and unknown if related to the device.

• Brand Name: TREVO XP PROVUE RETRIEVER 4X20
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): CONCENTRIC MEDICAL; 301 east evelyn; mountain view CA 94041
• MDR Report Key: 5967432
• Report Number: 0002954917-2016-00138
• Device Sequence Number: 704990
• Product Code: NRY
• UDI-Device Identifier: 04546540675880
• UDI-Public: (01)04546540675880(17)190731(10)19183538
• Combination Product (Y/N): N
• PMA/510(K) Number: K132641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2016

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
• Operator of Device: Health Professional
• Device Catalogue Number: 90182
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/31/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/21/2016
• Supplement Report FDA Received Date: 11/04/2016
• 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: ASPIRATION CATHETER (PENUMBRA); NEURON MAX BALLOON GUIDE CATHETER (PENUMBRA); TREVO 18 MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR