MAUDE Adverse Event Report: OPSENS SAVVYWIRE; PRE-SHAPED PRESSURE GUIDEWIRE

Model Number F3001

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

Patient Problem Vascular Dissection (3160)

Event Date 06/01/2023

Event Type  Death  

Manufacturer Narrative

Investigation of the savvywire used in the procedure is impossible since it was discarded by the hospital.According to the device history record, the lot number osw-0044 has been released following specifications, no dr nor nc were documented.It was confirmed to opsens that the wire was not showing any deficiencies when taking out of the patient, no bends nor kinks were noticed.The risks associated with the event are well documented and are disclosed in the savvywire instructions for use (ifu): adverse events that may result from the use of this device include, but are not limited to: access site or vessels complications, additional surgical procedure, allergic reactions, amputation, aneurysm, angina, arrhythmia, bleeding, cardiac or vessel perforation/dissection, coronary obstruction, death, embolism, fibrillation, foreign body/wire fracture, heart block, hematoma, hypotension/hypertension, infection, kidney injury/failure, myocardial infarction, need for permanent pacemaker, pericardial effusion, pneumothorax, stroke or other neurologic event, spasm, tamponade, thrombus, valve dysfunction or complications, vasospasm, vessel occlusion, wire entrapment/entanglement, x-ray radiation exposure complications.No additional actions are intended as a result of the incident.

Event Description

The event as described by opsens's sales rep: savvywire was properly deployed into the lv with no complications.As the edwards tavr valve was coming though the e sheath, they ruptured the descending aorta.The device ruptured the aorta where the patient had an aneurysm in the aorta.Once the wire was removed there were no kinks or bends.The wire did not show any deficiency.Opsens sales rep was informed the next day that the patient has expired.Opsens reached out to the physician, and he confirmed the event description.

• Brand Name: SAVVYWIRE
• Type of Device: PRE-SHAPED PRESSURE GUIDEWIRE
• Manufacturer (Section D): OPSENS; 750; blvd du parc technologique; quebec, quebec G1P 4 S3; CA G1P 4S3
• Manufacturer (Section G): OPSENS; 750; blvd du parc technologique; quebec, quebec G1P 4 S3; CA G1P 4S3
• Manufacturer Contact: maryem oudhini ; 750; blvd du parc technologique; quebec, quebec G1P 4-S3 ; CA G1P 4S3
• MDR Report Key: 17208870
• MDR Text Key: 317932423
• Report Number: 3008061490-2023-00005
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 07540184030019
• UDI-Public: (01)07540184030019(11)220912(17)240912(10)OSW-0044
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: F3001
• Device Catalogue Number: SAVVYWIRE XS
• Device Lot Number: OSW-0044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2023
• Initial Date FDA Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2022
• 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): Death