MAUDE Adverse Event Report: LAKE REGION MEDICAL SAFARI2¿; WIRE, GUIDE

Model Number	H74939407S0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: the patient was suitable for acurate neo2 size m.First valve smm470181 was implanted a bit higher, but due to pvl physicians decided to do post-dilatation.After good post-dilatation physicians removed safari wire without pigtail.First valve was moved higher probably due to safari touched the stabilization arch.Patient condition was stable, there was good blood flow to both coronaries, but patient had still paravalvular leak, physicians decided to implant second valve of same size.Second valve was implanted good (tavi in tavi).What was the patient condition following procedure? stable where did the problem occur? inside the patient was the problem associated with labeled use? yes action taken by the physician to try to resolve the event: observation.Event resolved? yes physician assessment of the relationship of the event to the device: related did patient have myocardial infarction <72 hours prior to procedure? no was the aortic annulus calcified? no was there prior brachytherapy of the target area? no what was the vascular access site? femoral & right was the iliofemoral severely tortuous? mild & moderate was the iliofemoral severely calcified? mild was there a significant bend involved in the lesion? no was valvuloplasty performed? no did the user encounter significant resistance? no was valvuloplasty performed? no annulus diameter (mm) 24.2 annulus perimeter (mm) 80 annulus ellipticity minimal diameter (mm) 23 calcification severe post balloon used (post) balloon 1 size (mm) 22 paravalvular leak grade 1 (mild) arch type type i guidewire used bmw universal guidewire additional information received 29mar2024: question: you mention that the valve was implanted, which was checked as "implanted" on both the valve and delivery system cnfs.Can you please help note why the delivery system will not return (disposed, etc.)? answer: the delivery system was disposed.Question: is the safari2 expected to return for analysis? if not, why (disposed, etc.)? if yes, when is the safari2 expected to return? answer: the safari 2 wire is not expected to return for analysis, because it was disposed.Question: if the safari2 is not available for return, is there an image available? answer: there is no image of safari2 wire used during the procedure.Question: were there any difficulties with positioning? if yes, please elaborate.Answer: there was some troubles during implanting the first implanted valve when it comes to height - probably due to calcium score (i do not have ct report, due to the fact that the patient was measured only by the physicians (trained in 3mensio)) - the valve was moving due to calcification - probably because of that the first valve position was high.Question: how was the procedure completed for the delivery system? (i.E.Was the same device exchanged for another of same, different device, etc.)? answer: new delivery system was used.Question: how was the procedure completed for the safari2 guidewire? (i.E.Was the same device exchanged for another of same, different device, etc.)? answer: the whole procedure was completed with this one safari.Question: were these implanters/users new or experienced? answer: the implanters are experienced and fully independent.Question: the valve was noted to be implanted 'a bit higher'.Was the valve still implanted in the intended location, or was it outside of the intended implant location? answer: the valve was implanted in the aortic annulus - the intended location - but the position was not perfect and not stable - after implantation patient has huge leakage.Question: was the cause of the pvl due to the valve location, under expansion, etc.? answer: the reason of pvl was provably valve location - too high and not stable (the valve was moved later).Question: what were possible contributing factors (comorbidities, anatomy, etc.)? answer: possible contributing factor was anatomy, huge calcium score and calcium extending to lvot.Question: what was the shape of calcium at the native aortic annulus? answer: in the aortic annulus there was a calcium but located externally.Question: what was the degree of tortuosity at the aortic arch? answer: there was a standard tortuosity of the aortic arch, around 45 degree.Question: was the valve size correct for the patient? answer: the valve size was correct for this patient.Question: when the first valve moved higher after the safari2 guidewire possibly touched the stabilization arch, did the first acurate neo2 valve lose contact with the annulus (i.E.Embolize vs.Migrate)? answer: the first implanted valve lose contact with the annulus.Question: can you please confirm when exactly the first valve moved? was this only after the safari2 wire was removed? answer: first valve moved few millimeters above the annulus - this was after safari wire removal and during implanting second valve the first valve also moved a bit higher.Question: was positioning of the first valve good prior to safari2 removal? answer: the position of the first valve was not perfect prior to safari removal, the position of 1st implanted valve was high since the beginning.Question: did the physician allege any specific difficulties experienced with the safari2 guidewire during the procedure? answer: the physicians did not claim any difficulties with safari wire during the procedure.The only possible issue is that the physicians did not remove the safari from the ventricle on pigtail.Question: was the guidewire lying along the septal wall with the loop facing up? answer: yes, the safari was lying along the septal wall with loop facing up.Question: was there any malfunction related to the safari2 guidewire? if yes, please elaborate.Answer: there were no issues with safari wire during the procedure.Question: the event description states, "after good post-dilatation physicians removed safari wire without pigtail." please note that per the instructions for use (ifu), the wire should only be introduced into or withdrawn from the ventricle through a catheter already positioned in the ventricle.What was the reason for removing the [?]safari wire without pigtail?' answer: the wire should be withdrawn from the ventricle through a catheter positioned in the ventricle, but the physicians did not do this, despite i was mentioned about that.Question: the event description states, "first valve smm470181 was implanted a bit higher" and then goes on to state, "first valve was moved higher probably due to safari touched the stabilization arch." was this movement noted on fluoroscopy during the procedure or on images after the procedure or what was the reason for reporting? first valve was moved higher probably due to safari touched the stabilization arch'? answer: the first valve position was high since the beginning of implantation, it was difficult to position the valve good probably due to calcium.The valve position was high, but after post-dilatation and safari removal the valve dislodged higher.Question: was there any resistance noted during withdrawing the safari2 guidewire? answer: i am not aware of any resistance during withdrawing safari wire.Question: which cusp was the pigtail set in? answer: the pigtail was at the bottom of the non-coronary cusp.Question: was there neutral tension applied to the delivery system during deployment? answer: there was neutral tension during deployment.Question: what intervention was performed after the first valve moved higher? was the valve snared to a new location? where? answer: the valve was not snared because there was a risk to destroy the coronary arteries ostium.Question: what was the final location of the first valve after valve-in-valve? answer: final location of 1st valve was approximately centimeter above the annulus.There was no blockage to coronaries.Patient condition was stable.Question: following valve-in-valve, are the two valves overlapping and a true valve-in-valve? answer: the two valves was overlapping and it was a true valve-in-valve.Question: what was the severity of the paravalvular leak before post-dilatation? was the paravalvular leak pre-existing? if yes, what was the severity? answer: no information about paravalvular leak before the procedure available.Question: what was the severity of the leak after movement of the first valve? answer: the leak severity was moderate.Question: after the first valve was implanted and post dilatation performed (before safari2 interaction), was the pvl considered resolved? answer: the leak was smaller.Question: after the first valve moved, did the pvl return? answer: the pvl return after first valve moved.Question: in the end user's opinion, was there any relationship between the decision to implant a second valve and the use of the safari2 guidewire? please explain.Answer: the physicians decided to remove the safari from the ventricle because they thought the pvl decreased, but after safari removal they noticed the valve was dislodged higher and pvl was big at that moment.Then the decision about valve-in-valve/implanting 2nd valve was made.Question: was there any paravalvular leak after valve-in-valve? if yes, what was the severity? answer: there was still pvl after implanting 2nd valve, but smaller.The physicians decided to end the procedure with this acceptable leak.Question: what is the status of the patient post procedure? was the patient discharged home and on what date was the patient discharged home? answer: yes the patient was discharged home, no information about specific date of discharged available.
Additional Manufacturer Narrative
Product was disposed; therefore, no physical or visual analysis could be performed.A review of the device history records of the specimen device does not present any indication of manufacturing defect or anomaly that could have impacted on the event as reported.During manufacturing and packaging of this product the operators are instructed to 100% visually inspect for any obvious defect prior to shipment.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.As indicated in the device instructions for use (dfu) warnings section: · monitor wire position throughout the procedure for proper placement of the curve and distal tip.· when advancing or removing the guidewire, always use fluoroscopic guidance with radiographic equipment that provides high-resolution images.Never position the guidewire blindly, as this may result in misplacement, dissection or perforation.· never advance the guidewire against resistance without first determining the reason for resistance under fluoroscopy.Excessive force against resistance may result in damage to the catheter or vessel/organ.Care should be taken when advancing the guidewire after device deployment.· the wire should only be introduced into or withdrawn from the ventricle through a catheter already positioned in the ventricle.· the curve of the safari2 guidewire should be constrained with in a catheter during insertion into or withdrawal from the body or treatment site.As indicated in the device instructions for use: 1.Ensure a catheter is appropriately placed in the ventricle or other intended treatment area.2.Carefully remove the safari2 guidewire, from the hoop by grasping the proximal end of the j-straightener separating the straightener from the hoop.3.After inspection of the safari2 guidewire, advance the j-straightener over the distal section of the safari2 wire to straighten the curve.4.Insert the safari2 guidewire into the hub of the catheter with the aid of the j- straightener.5.Carefully advance the distal tip of the safari2 guidewire into the lumen of the catheter.6.Remove the safari2 guidewire j- straightener by withdrawing it over the length of the safari2 guidewire.7.Advanced the safari2 guidewire through the catheter under fluoroscopic guidance.8.Confirm safari2 guidewire curve position to assure safari2 guidewire placement and stability.9.Maintain wire position while tracking or advancing a catheter or device over the wire.10.To remove the guidewire from the treatment area: a.A catheter must be advanced into the treatment area over the safari2 guidewire prior to withdrawing the wire.B.The safari2 guidewire is pulled back completely into the catheter.C.The safari2 guidewire may then be withdrawn from the catheter.Please note: although there were no reported issues with the safari2 guidewire during the procedure and no report of serious injury, the information received reported that after removal of the safari2 guidewire it was noted that the valve was dislodged higher and paravalvular leak was big at that moment.Valve complications is listed in the instructions for use (ifu) as a potential adverse event.At this time, it is not possible to assign a definitive root cause for the event as reported.Based on the information provided, it appears that clinical and/or procedural factors have contributed to the event.If there is any further relevant information received, a follow up medwatch report will be submitted.
Additional Manufacturer Narrative
Correction to a previously submitted mdr to correct the brand name in section d1 and the catalog number and primary unique device identifier (udi) number in section d4.

• Brand Name: SAFARI2¿
• Common Device Name: WIRE, GUIDE
• Manufacturer (Section D): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska MN 55318
• Manufacturer (Section G): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: sharon seifert ; 340 lake hazeltine drive; chaska, MN 55318 ; 9526418518
• MDR Report Key: 19014213
• Report Number: 2126666-2024-00024
• Device Sequence Number: 20872066
• Product Code: DQX
• UDI-Device Identifier: 08714729887652
• UDI-Public: (01)08714729887652(17)260911(10)8256726
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K151244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/11/2026
• Device Model Number: H74939407S0
• Device Catalogue Number: H74939407S0
• Device Lot Number: 8256726
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/01/2024
• Supplement Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female