MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY 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 Problems Anaphylactic Shock (1703); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/21/2021

Event Type  Injury  

Manufacturer Narrative

This is 1 of 2 reports.H3 other text: the subject device is unavailable to manufacturer.

Event Description

It was reported that between end of procedure and 1 day post procedure follow-up from a thrombectomy procedure on (b)(6) 2021, patient experienced anaphylactic shock and instable arterial pressure due to contrast agent injection which was treated with the medication.It is noted that the adverse event has possibly relationship to the subject study retriever device, thrombectomy procedure, and to an underlying condition.The outcome of the adverse event was resolved on (b)(6) 2021 without clinical sequalae.No further information is available.

Manufacturer Narrative

Section b1 adverse event: corrected: no adverse event.Section b2 outcomes attributed to ae: corrected: no other serious (important medical.Events) / no required intervention to prevent permanent impairment/damage (devices)/ no hospitalization-initial or prolonged, section h1 type of reportable event: corrected: no serious injury.F10 / h6 device code grid - corrected to '¿no apparent adverse event¿.F10 / h6 - clinical signs code grid: corrected to ¿no clinical signs, symptoms or conditions¿.F10 / h6 - health impact code grid: corrected to ¿no health consequences or impact¿.H6 conclusion code grid: corrected - no 'conclusion not yet available'.Based upon medical review, the adverse event information and sae (serious adverse event) of the anaphylactic shock and instable arterial pressure occurred between end of procedure and 1 day post procedure follow-up was concluded to be related to the contrast agent.There is no allegation alleged against the subject trevo device that could have contributed to the adverse events of anaphylactic shock and instable arterial pressure.Therefore, the event does not meet the requirements of a reportable event for the corresponding subject trevo device.Based on the information, this complaint is not subject to mdr reporting regulation 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 between end of procedure and 1 day post procedure follow-up from a thrombectomy procedure on (b)(6) 2021, patient experienced anaphylactic shock and instable arterial pressure due to contrast agent injection which was treated with the medication.It is noted that the adverse event has possibly relationship to the subject study retriever device, thrombectomy procedure, and to an underlying condition.The outcome of the adverse event was resolved on (b)(6) 2021 without clinical sequalae.No further information is available.Update: based upon medical review, the adverse event information and sae (serious adverse event) of the anaphylactic shock and instable arterial pressure occurred between end of procedure and 1 day post procedure follow-up was concluded to be related to the contrast agent.There is no allegation alleged against the subject trevo device that could have contributed to the adverse events of anaphylactic shock and instable arterial pressure.Therefore, the event does not meet the requirements of a reportable event for the corresponding subject trevo device.Based on the information, this complaint is not subject to mdr reporting regulation.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

• 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
• Manufacturer (Section G): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 17077997
• MDR Text Key: 316672459
• Report Number: 3012931345-2023-00126
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K120961
• 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: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2023
• 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
• Treatment: CATALYST 6F (STRYKER).
• Patient Outcome(s): Other; Hospitalization; Required Intervention