MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY UNKNOWN_NEUROVASCULAR_PRODUCT; CATHETER, THROMBUS RETRIEVER

Catalog Number UNK_NEU

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

Patient Problem Embolus (1830)

Event Date 08/20/2019

Event Type  Injury  

Manufacturer Narrative

This is 1 of 2 reports.The subject device is unavailable to manufacturer.

Event Description

It was reported that during treatment of the occluded in m1 segment of the middle cerebral artery (mca), an emboli to new territory (ent) had occurred in the a1 segment of the anterior cerebral artery (aca) and medical intervention was performed to treat the patient¿s ent.The procedure was successfully completed, and the patient was assessed having a thrombolysis in cerebral infarction (tici) score of 3.Patient status directly after the procedure is fine with no significant disability and able to carry out all usual duties and activities.

Event Description

It was reported that during treatment of the occluded in m1 segment of the middle cerebral artery (mca), an emboli to new territory (ent) had occurred in the a1 segment of the anterior cerebral artery (aca) and medical intervention was performed to treat the patient¿s ent.The procedure was successfully completed, and the patient was assessed having a thrombolysis in cerebral infarction (tici) score of 3.Patient status directly after the procedure is fine with no significant disability and able to carry out all usual duties and activities.

Manufacturer Narrative

Although the lot number was not provided, the automated manufacturing execution system (mes) has controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be 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.The reported patient embolus 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 was assigned to this event.

• Brand Name: UNKNOWN_NEUROVASCULAR_PRODUCT
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• MDR Report Key: 9199715
• MDR Text Key: 162859767
• Report Number: 3012931345-2019-00080
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• PMA/PMN Number: K132641
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup
• Report Date: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_NEU
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BALLOON GUIDE CATHETER (STRYKER)
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 75 YR