MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK UNKNOWN_NEUROVASCULAR_PRODUCT; PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)

Catalog Number UNK_NEU

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); No Consequences Or Impact To Patient (2199)

Event Date 02/06/2020

Event Type  Injury  

Manufacturer Narrative

This is 4 of 4 reports.The subject device is unavailable to manufacturer.

Event Description

It was reported that beond 48 hours after the study procedure, the patient developed a stroke from the right middle cerebral artery (m1) region which resulting in inpatient hospitalization.Medical management was administered, and the event was resolved in the next day.The study facility reported that the relationship of the stroke to the subject device aspiration pump, retriever, the distal access catheter, the balloon guide catheter and to the index procedure.No further information is available.

Manufacturer Narrative

Section b5 - executive summary: update: based on additional information received from the site on 1-may-2020 clarified that there was no relationship between the adverse event patient¿s stroke with the subject device retriever.Since there was no adverse event and no reported malfunction of the device that could have caused or contributed to an adverse event, this event does not meet reporting criteria anymore.Section b1: adverse event/product problem: corrected: no adverse event or product problem section b2: outcomes attributed to ae: corrected: no other serious (important medical events).Section h1: type of reportable event: corrected: removed serious injury - no serious injury.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

Event Description

It was reported that beyond 48 hours after the study procedure, the patient developed a stroke from the right middle cerebral artery (m1) region which resulting in inpatient hospitalization.Medical management was administered, and the event was resolved in the next day.The study facility reported that the relationship of the stroke to the subject device aspiration pump, retriever, the distal access catheter, the balloon guide catheter and to the index procedure.No further information is available.Update information : based on additional information received from the site on 1-may-2020 clarified that there was no relationship between the adverse event patient¿s stroke with the subject device aspiration pump.Since there was no adverse event and no reported malfunction of the device that could have caused or contributed to an adverse event, this event does not meet reporting criteria anymore.

• Brand Name: UNKNOWN_NEUROVASCULAR_PRODUCT
• Type of Device: PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 9935956
• MDR Text Key: 186835141
• Report Number: 3002807523-2020-00001
• Device Sequence Number: 1
• Product Code: BTA
• Combination Product (y/n): N
• PMA/PMN Number: K170329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_NEU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AXS CATALYST 7 DISTAL ACCESS CATHETER (STRYKER).; FLOWGATE² BALLOON GUIDE CATHETER (STRYKER).; TREVO XP PROVUE RETRIEVER 4X30 (STRYKER).; AXS CATALYST 7 DISTAL ACCESS CATHETER (STRYKER); FLOWGATE² BALLOON GUIDE CATHETER (STRYKER); TREVO XP PROVUE RETRIEVER 4X30 (STRYKER)
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 58 YR