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

Model Number F3001

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem Pericardial Effusion (3271)

Event Date 06/13/2023

Event Type  Injury  

Event Description

The event as described by opsens clinical specialist: on tuesday june 13th, the physician was performing a tavr with the savvywire (lot osw-0062 expiration 1/4/25).He introduced the savvywire into the ventricle without a pigtail catheter; when we noticed the wire was not in the apex, we encouraged him to advance the wire to the apex.He replied, "this is a different angio view", meaning in this view its hard to tell if the wire was in the apex.The medtronic valve was then introduced into the body and advanced up and over the aortic arch.Now being in the rao projection, the savvywire was still not in the apex, but the physician continued advancing the valve delivery system across the valve.When the nose cone crossed the valve, the tip of the savvywire straightened out abruptly and stayed that way until the physician did some wire manipulations.After that, the wire did go back to its pigtail form but there was a noticeable kink a couple millimeters below the fidela sensor.The physician then continued with the procedure and deployed the valve.No pacing was performed at all because the patient's pressure was so low.The doctor then removed the delivery system and wire because the patient's systolic pressure remained in the 40's after the medtronic valve was deployed.An echocardiogram was quickly performed, which showed that the patient had developed a pericardial effusion.The tavr team was unable to get the pericardial effusion under control, and the patient was taken to the or for further intervention.Opsens reached out to the hospital to obtain information about the patient's status after the procedure, the hospital confirmed that the patient underwent an lv repair and was discharged from the hospital few days after.

Manufacturer Narrative

Check of the device history records confirmed that lot number osw-0062 was released according to specifications.No deviations nor ncrs were associated to this lot.Investigation of the returned savvywire confirmed the event description, a kink was noticed in the stiff portion of the tip close to the sensor housing.From the extent of the kink, we can assume that some excessive manipulations were performed.Basing on the event's description, the savvywire's tip straightened out abruptly, it was most likely entrapped behind some structure in the ventricle, leading the physician to preform some excessive wire manipulations, in addition to the stiffness and force of the delivery system coming across the aortic valve.All those circumstances might have contributed to the observed kink.The risks associated with the unfortunate 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.The ifu also mentions the following precaution such as: never advance, pull or torque a savvywire against resistance without first determining the reason for the resistance under fluoroscopy.Excessive force against resistance may result in damage to the wire and/or to the anatomy.Fluoroscopic guidance should be used during manipulations of the savvywire.Care should be taken when the tip of the savvywire is positioned, moved or torqued in the ventricle.

• 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: 17298657
• MDR Text Key: 318919369
• Report Number: 3008061490-2023-00006
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 07540184030019
• UDI-Public: (01)07540184030019(11)230104(17)250104(10)OSW-0062
• 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: F3001
• Device Lot Number: OSW-0062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2023
• Initial Date FDA Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2023
• 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): Hospitalization