MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION CONFIDA BRECKER CURVE GUIDEWIRE; WIRE, GUIDE, CATHETER

Model Number GWBC30

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Low Blood Pressure/ Hypotension (1914); Rupture (2208); Cardiac Perforation (2513)

Event Date 07/11/2022

Event Type  Injury  

Event Description

Medtronic received information that during the implant of a transcatheter bioprosthetic valve, the guidewire crossed the native valve into the left ventricle.When the pre-dilation balloon was advanced via the guidewire, the guidewire was pushed and the left ventricular apex was perforated as confirmed by echocardiogram.The blood pressure decreased and an intra-aortic balloon pump (iabp) was required.As reported, repair via a thoracotomy was required to place suture.Per the physician the calcification of the native annulus may have contributed to the perforation.The physician reported that the guidewire appeared thin, in the transition part of the from 0.03 to 0.035, via fluoroscopy.As reported, this ¿thin¿ area was not evident prior to the guidewire use.Upon removal from the patient, the transition portion of the guidewire was recognized but the ¿thin¿ portion was not identified.A different manufacturer¿s guidewire was then used for the transcatheter valve implant.The day following the hemodynamics were stable.No additional adverse patient effects were reported.

Manufacturer Narrative

Product analysis: the device was not returned, therefore no product analysis can be performed.Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the guidewire was received coiled inside its hoop.The distal end of the guidewire appeared bent at the coil / core wire transition point.The distal end and j tip area of the guidewire appears bent exhibiting signs that the user may have manipulated the j tip of the guidewire.The glued distal tip is intact, however, there are multiple scratches on the proximal coils.There is also a kink on the coil / core wire transition area.The tapered glue bond adjacent to the coil / core wire transition area has been broken.There are multiple scratches on the ptfe coating along the core wire and a kink / bend observed on the core wire.Conclusion: review of the returned angiographic images showed in the cines that there appeared to be a buckling in the wire in the left ventricle, from what was reported as the pre dilation balloon.Another image showed the wire prolapsed in the left ventricle.Another image of the pre implant valvuloplasty, there is an appearance of a "halo" around the heart which is a sign of a pericardial effusion which was caused by the reported perforation.The event description also stated that the guidewire was pushed during the pre dilation balloon was advanced and the apex of the ventricle was perforated.The perforation appears to have occurred during the pre dilation balloon was being dilated, which is confirmed in the images with a "halo" that indicates that effusion has occurred as a result of a perforation, which most likely led to the reported hypotension.Hypotension / hypovolemia is a known potential adverse effect per the instructions for use (ifu) and risk documents.It is an effect that is highly dependent on the patient's pre-procedural condition and can occur despite a normally-functioning device or model implant procedure.In this case hypotension is most likely a secondary harm as the result of the perforation that occurred when the guidewire was pushed into the left ventricle during the reported pre balloon aortic valvuloplasty (bav).The ifu instructs that it is critical that the guidewire is controlled to prevent it from moving forward.The ifu also cautions that without proper management of the distal tip of the guidewire, the guidewire could move forward and cause trauma/ perforation to the left ventricle, as occurred in this case.In addition, the analysis of the returned guidewire shows evidence of the j tip are to have been manually bent or shaped.The confida brecker guidewire consists of a pre-formed shape of the flexible distal tip which is specifically designed to position the guidewire in the left ventricle (lv) and mitigate the variability associated with the distal tip of regular guidewires.It also eliminates the need for physicians to manually bend the guidewire during the transcatheter aortic valve replacement (tavr) procedure, or other diagnostic and interventional catheterization procedures.In terms of tavr procedures, this pre-formed shape of the flexible distal tip is designed to provide stability for a tavr delivery system tracked over the guidewire and to mitigate the risk of lv perforation.In addition, cardiac perforation is a known potential patient adverse effect per the ifu.It is an effect that is highly dependent on the patient's pre-procedural condition and can occur despite a normally-functioning device or model implant procedure.The reported "thin" area that the user reported was not able to be confirmed.However, there was an area at the coil to core wire tr ansition area in which there is a bend in the core wire that was most likely due to the buckling in the wire that was noted on the angios, that occurred as a result of the pre dilation balloon.The bend and broken bond at the core to coil wire transition point, was noted at receipt, with this section of the guidewire remaining outside the packaging hoop, so its unknown if this damage to the bond and the bend may have occurred as the customer was loading the guidewire back into the hoop, the user manually pre shaped/ bent the guidewire prior to use, or if this damage did indeed occur during the "buckling" that occurred during the pre implant bav, if the user wasn't controlling the position of the guidewire.As a result of receiving this event, this guidewire has been forwarded to the manufacturer, for further analysis and to make them aware of the event.This event does not indicate device manufacturing related malfunction.Updated data: a1 - patient identifier d9 - device available for evaluation and return date h3 - device evaluated, device returned to manufacturer and eval summary attached boxes checked h6 - method, results and conclusion codes.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received that during the valve implant, an annular rupture occurred resulting in repair via a thoracotomy.No additional adverse patient effects were reported.

• Brand Name: CONFIDA BRECKER CURVE GUIDEWIRE
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 15143184
• MDR Text Key: 297030193
• Report Number: 2025587-2022-02150
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K132623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GWBC30
• Device Catalogue Number: GWBC30
• Device Lot Number: 92100322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2021
• 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): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female