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 Problems Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 11/15/2022

Event Type  Death  

Manufacturer Narrative

Investigation of the wire is not possible as the hospital discarded it by the end of the procedure, after review of order data, only 2 lot numbers from savvy wire x small size were shipped to (b)(6) (osw- 0040 & osw-0028), both lots number has been released following specifications, no dr nor nc were documented.As stated from the physician the source of the pericardial effusion is unknown.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.

Event Description

The event was reported as follows from the physician to opsens sales team: patient presented for tavr at (b)(6) medical center on (b)(6) 2022.Patient did not have adequate ct scan for annular sizing and another ct scan was requested by device rep but was denied by physicians.The physician decided on a nominal prepped 26 mm s3 for implant.Patient was not a candidate for conversion to open heart surgery due to multiple comorbidities.Procedure was event free during access, valve crossing, and lv wire pacing testing.The savvywire was placed in the lv utilizing a 6 fr pigtail without issue.Lv pacing was tested using best practice techniques.The threshold was tested and lost capture at 7 ma.The pacer box was then programmed to max output for lv pacing.The valve was inserted without issues over the savvywire.During balloon inflation for valve deployment, savvywire looked to be in good position with capture noted.At 50% balloon inflation, the patient had what appeared to be pvc and lost pacing capture.The valve popped out of the annulus into the ascending aorta.Patient was stable throughout multiple balloon inflations to secure valve in ascending ao.Cath lab staff prepped a second valve of 26 mm + 2 cc to increase valve size for unsized annulus and rv pacer inserted.Team tested the rv pacer and lost capture at 2 ma.Second valve deployed without issue.Within minutes, the patient experienced rapid heart rate and hypotension.Cpr was started due to mean arterial pressure in 30s.Tte noted pericardial effusion with unknown origin.The physician proceeded with pericardiocentesis and drained excessive amount of bright red blood consistent with that of annular rupture.The physician attempted to apply surgiflo to effusion site without long term success.After multiple rounds of cpr, patient expired.After debriefing with team and physician, the doctor noted he did not have forward pressure on the savvywire during lv pacing.This is his normal practice during deployment as he is not accustomed to lv pacing and utilizes amplatz wire for valve delivery.Without forward pressure on the savvywire during balloon inflation, the tension created can cause the wire to move and possibly lose capture.I mentioned this to the doctor as a potential learning opportunity for future cases.We discussed the size of the xs versus sm savvywire and he would like additional information on lv sizing for wire selection.The doctor feels the pvc with subsequent pop out was the catalyst of the poor outcome.

• Brand Name: SAVVYWIRE
• Type of Device: PRE-SHAPED PRESSURE GUIDEWIRE
• Manufacturer (Section D): OPSENS; 750; boulevard parc technologique; quebec, quebec G1P 4 S3,C; CA G1P 4S3,CA
• Manufacturer (Section G): OPSENS; 750; boulevard du parc technologiqu; quebec, quebec G1P 4 S3; CA G1P 4S3
• Manufacturer Contact: maryem oudhini ; 750; boulevard du parc technologiqu; quebec, quebec G1P 4-S3 ; CA G1P 4S3
• MDR Report Key: 16359012
• MDR Text Key: 309369973
• Report Number: 3008061490-2022-00004
• Device Sequence Number: 1
• Product Code: DXO
• 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: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2022
• 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): Death