MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION RING 620RG29 DURAN ANCORE ANNULOPLASTY C; RING, ANNULOPLASTY

Model Number	620RG29
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Deformation Due to Compressive Stress (2889); Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that immediately post implant of this 29mm mitral annuloplasty ring, it was explanted and replaced with a non-medtronic ring of a larger size.The physician intended to implant a 31mm medtronic ring originally, but the hospital did not have one in stock, and therefore the physician attempted the 29mm ring of the same model.It was noted that the patient's annulus was too large compared to the 29mm ring.No additional adverse patient effects were reported. .
Additional Manufacturer Narrative
Product analysis: upon receipt at medtronic¿s quality laboratory, the ring was discolored showing evidence of blood contact.The ring appeared to have been modified into a band with each end cut.Deformations and bends were noted along the ring.Radiography revealed deformation along the ring; however, no calcification and/or fractures were observed.Conclusion: surgeons often attempt to repair valves in lieu of replacing them in an effort to preserve the native anatomy.There are times when valve repair is attempted using a repair device and subsequent post-repair evaluation demonstrates an inadequate result.Failures in the acute period (less than 30 days from implant) are often unsuccessful repairs.This is potentially due to, but not limited to, suboptimal anatomy, surgical technique or inappropriate sizing, and not a malfunction of the device.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: RING 620RG29 DURAN ANCORE ANNULOPLASTY C
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 8533176
• Report Number: 2025587-2019-01282
• Device Sequence Number: 1839788
• Product Code: KRH
• UDI-Device Identifier: 00643169793392
• UDI-Public: 00643169793392
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K032810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/25/2023
• Device Model Number: 620RG29
• Device Catalogue Number: 620RG29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Initial Date Received by Manufacturer: 03/29/2019
• Supplement Date Received by Manufacturer: 06/19/2019
• Initial Report FDA Received Date: 04/19/2019
• Supplement Report FDA Received Date: 07/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention