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

Model Number 505DA18

Device Problems Backflow (1064); Incomplete Coaptation (2507); Mechanical Jam (2983)

Patient Problem Aortic Regurgitation (1716)

Event Date 02/07/2020

Event Type  Injury  

Manufacturer Narrative

Citation: miyata k et al.Intraoperative detection of stuck leaflet after implantation of a mechanical aortic valve: a case report.Ja clin rep.2020 feb 7;6(1):9.Doi: 10.1186/s40981-020-0313-3.Earliest date of publish used for event date.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.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding a (b)(6)-year-old female patient (weight (b)(6) kg) with a history of aortic valve stenosis, aortic regurgitation, left ventricular overload hypertrophy, hypertension, hyperlipidemia, and type 2 diabetes mellitus who underwent surgical aortic valve replacement with a 18 mm medtronic open pivot (ats) mechanical aortic valve (serial number not provided).Before weaning off cardiopulmonary bypass (cpb), intra-operative transesophageal echocardiography (io-tee) revealed severe transvalvular aortic regurgitation that originated in the intra-sewing ring of a non-coronary cusp and was not located at the point of the hinges.A second cpb was initiated.Following re-aortic-cross-clamping and aortotomy, it was noted that residual suture material placed in the sewing ring was caught in one leaflet and interfered with leaflet closure.Subsequently, the residual suture material was cut away and appropriate leaflet motion was restored.The patient was weaned from the second cpb and io-tee showed no transvalvular regurgitation.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Additional information received from the physician/author stated that medtronic product was related to the observed adverse events.Additional information received from the physician/author also provided the device model number.Updated data: d.4 - model # and catalog # updated to 505da18.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

Additional information received from the physician/author stated that the valve cannot be returned because it remains implanted in the patient.Updated data: h.6 - eval code method 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, INC.; 3800 annapolis lane; minneapolis MN 55447
• MDR Report Key: 9771490
• MDR Text Key: 185603928
• Report Number: 3008592544-2020-00013
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup,Followup
• Report Date: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 505DA18
• Device Catalogue Number: 505DA18
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 65