MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION OPEN PIVOT STANDARD AORTIC HEART VALVE; HEART-VALVE, MECHANICAL

Model Number 500FA

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

Patient Problems Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Pseudoaneurysm (2605)

Event Date 04/24/2022

Event Type  Injury  

Event Description

Medtronic received information via literature regarding a 59-year-old-male patient who approximately 10 years prior received a medtronic ats open pivot aortic valved graft (unique device identifier numbers not provided) to treat dilatation of the aortic-arch.  over the next seven years the patient underwent numerous re-interventions to treat endo leaks in the aorta.  more recently the patient presented with abdominal pain.  computed tomography (ct) found pseudoaneurysm at the anastomosis to the celiac trunk and pseudoaneurysm between the brachiocephalic trunk and the aortic arch graft.  a two-phase open surgery was planned.  in the first procedure the pseudoaneurysm at the celiac trunk was treated with implant of a non-medtronic covered stent.  two weeks later, in the second procedure, a non-medtronic septal occluder was implanted at the brachiocephalic trunk to aortic arch graft site.  final angiography showed a minimal residual perfusion of the pseudoaneurysm with the occluder in a stable position.  postprocedural the patient experienced a temporary minor stroke with dysarthria and weakness of the right arm.  at three-month follow-up, the patient demonstrated stable pseudoaneurysm diameter with minimal perfusion at the level of the aortic arch.  at five months postprocedural the patient was noted in stable condition with complete neurological recovery. no additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Citation: vogel et al.Pseudoaneurysm repair with a septal occluder.Vasc endovascular surg.2022 aug;56(6):628-630.Doi: 10.1177/15 385744221095922.Epub 2022 apr 24.Earliest date of publication used for date of event.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.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 received from the physician/author stated that medtronic product did not cause or contribute to the observed adverse events.No further details were provided.

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.

• Brand Name: OPEN PIVOT STANDARD AORTIC HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• 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: 16219412
• MDR Text Key: 307877031
• Report Number: 2025587-2023-00199
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 500FA
• Device Catalogue Number: 500FA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2023
• 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): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Male