MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-CALIF UNKNOWN_NEUROVASCULAR_PRODUCT; CATHETER, THROMBUS RETRIEVER

Catalog Number UNK_NEU

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

Patient Problem Vasoconstriction (2126)

Event Date 11/20/2023

Event Type  Injury  

Manufacturer Narrative

This is 4 of 7 reports (4th mdr).H3 other text : the device is not available for evaluation.

Event Description

The survey conducted in united states.Results from the survey stated that adverse events (vasospasm) were reported.No other information was provided.

Manufacturer Narrative

Upon re-review of the study details, it is clarified that there was no patient treatment required and the patient recovered completely from the reported vasospasm adverse event involving the vecta 71.The physician did not take any action/intervention due to this event.There was no reported permanent impairment of a body function or permanent damage to a body structure, no medical or surgical intervention to prevent permanent impairment of a body function or structure was performed and the event was not life threatening.There was no information to reasonably suggest that this type of malfunction would likely cause or contribute to a death or serious injury if the malfunction were to reoccur.Therefore, this event does not meet reporting criteria anymore.The manufacturer has re-reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

Event Description

The survey conducted in united states.Results from the survey stated that adverse events (vasospasm) were reported.No other information was provided.Update 18-dec-2023: upon re-review of the study details, it is clarified that there was no patient treatment required and the patient recovered completely from the reported vasospasm adverse event involving the vecta 71.

• Brand Name: UNKNOWN_NEUROVASCULAR_PRODUCT
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-CALIF; 47900 bayside parkway; fremont CA 94538
• Manufacturer (Section G): STRYKER NEUROVASCULAR-CALIF; 47900 bayside parkway; fremont CA 94538
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 18232113
• MDR Text Key: 329315919
• Report Number: 3008853977-2023-00050
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other