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 Stroke/CVA (1770); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/03/2020

Event Type  Death  

Manufacturer Narrative

The device is not available to the manufacturer.

Event Description

It was reported between end of procedure and 1 day post procedure follow-up from a thrombectomy procedure on the (b)(6) 2020, the patient suffered from a malignant brain oedema, left sylvian malignant infarction and death.Medication was administered.It was reported there was a possible relationship between the adverse event and the subject study retriever device.It was reported the stroke (disease under study) and the thrombectomy procedure were related to the adverse event.No further information is available.

Event Description

It was reported between end of procedure and 1 day post procedure follow-up from a thrombectomy procedure on the (b)(6) 2020, the patient suffered from a malignant brain oedema, left sylvian malignant infarction and death.Medication was administered.It was reported there was a possible relationship between the adverse event and the subject study retriever device.It was reported the stroke (disease under study) and the thrombectomy procedure were related to the adverse event.No further information is available.It was confirmed on 30 aug 2023 that the same reported event details, facility, device, and event date captured in this event was already captured under mfr report number: 3012931345-2023-00134.Therefore this complaint no longer meets reporting criteria and a supplemental will be filed as a duplicate/cancellation record.

Manufacturer Narrative

Emdr data file attachment: updated.B5 executive summary: updated.F10/h6 clinical signs code grid: updated.F10/h6 health impact code grid: updated.F10/h6 device code grid: updated.It was confirmed on 30 aug 2023 that the same reported event details, facility, device, and event date captured in this event was already captured under mfr report number: 3012931345-2023-00134.Therefore this complaint no longer meets reporting criteria and a supplemental will be filed as a duplicate/cancellation record.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: 17426288
• MDR Text Key: 320061393
• Report Number: 3012931345-2023-00173
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K150616
• 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: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2023
• 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: 08/30/2023
• 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: SOFIA 6F PLUS CATHETER (MICROVENTION)
• Patient Outcome(s): Death