MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION TRU SIZE SIZERS; SIZER, HEART-VALVE, PROSTHESIS

Model Number 7400S

Device Problems Break (1069); Detachment of Device or Device Component (2907); Scratched Material (3020)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2021

Event Type  malfunction  

Manufacturer Narrative

Product analysis: the device has been returned and analysis is in progress.A supplemental report will be filed upon its completion.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during the use of this aortic valve sizer, while sizing the patient's aortic valve, a piece of the polysulfone connecting the sizer to the stem detached and fell into the patient's left ventricle.The main fragment was recovered, but it is uncertain if all the polysulfone was removed.No adverse patient effects were reported.Additional information was received that this aortic valve sizer has been used approximately 27 times prior to the incident.It was reported that the facility's process for sterilizing the sizer was a steam autoclave at 134°c for 20 minutes.It was also reported that the patient is safe and no adverse patient effects were reported. .

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, visual examination revealed that the barrel end was broken in multiple pieces.The replica end exhibited signs of crazing, which is consistent with historical events associated with multiple sterilization cycles.Signs of crazing were observed on the barrel end.No damages were observed on the metal rod.The metal rod was inserted and appeared to seat comfortably within the opening of the barrel end.Conclusions: the investigation is still in progress.A supplemental report will be filed upon its completion.H3: device evaluated? updated.H6: coding updated.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

Conclusions: the instructions for use (ifu) lists warnings, "do not use damaged sizers.Although these sizers are intended for multiple use, replace the sizers if surface deterioration occurs.Carefully inspect each sizer before use for cracks or flaws that may result from sterilization, handling, or general use.Do not use any sizer that shows excessive signs of wear or other damage." a review of medtronic's complaint handling database showed that this was the only complaint event related to broken sizers for this model.The root cause of the broken sizer could not be confirmed.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: TRU SIZE SIZERS
• Type of Device: SIZER, HEART-VALVE, PROSTHESIS
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 11456149
• MDR Text Key: 240960206
• Report Number: 2025587-2021-00814
• Device Sequence Number: 1
• Product Code: DTI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 7400S
• Device Catalogue Number: 7400S
• Device Lot Number: ST2676913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2021
• Date Manufacturer Received: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1