MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION CG FUTURE BAND; RING, ANNULOPLASTY

Model Number	638RL30
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); Cusp Tear (2656); No Information (3190)
Date of Event	07/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 annuloplasty ring, the ring was explanted and replaced with an unknown device.The reason for the replacement was not reported.No additional adverse patient effects were reported. .
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that at the time of suture, the patient's native valve was torn due to calcification and was not able to be repaired with the 30mm annuloplasty ring.Subsequently, the 30mm ring was explanted and replaced with a larger ring of the same model.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Product analysis: upon receipt at medtronic¿s quality laboratory, visual inspection noted that there was no blood content evident on the returned annuloplasty ring, and it appeared in tact with no evidence of distortion or fracture.Radiology showed no fractures or deformations along the ring.Conclusion: based on the analysis, the cause of the event cannot be determined.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CG FUTURE BAND
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 7772822
• Report Number: 2025587-2018-02095
• Device Sequence Number: 19112139
• Product Code: KRH
• UDI-Device Identifier: 00613994758651
• UDI-Public: 00613994758651
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K061127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/19/2019

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: 09/29/2021
• Device Model Number: 638RL30
• Device Catalogue Number: 638RL30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2019
• Initial Date Received by Manufacturer: 07/20/2018
• Supplement Date Received by Manufacturer: 09/07/2018; 04/03/2019
• Initial Report FDA Received Date: 08/10/2018
• Supplement Report FDA Received Date: 09/17/2018; 04/19/2019
• 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