MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. TAILOR FLEXIBLE ANNULOPLASTY BAND; RING, ANNULOPLASTY

Model Number	TAB-29
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Pleural Effusion (2010); Heart Failure/Congestive Heart Failure (4446)
Date of Event	03/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
On (b)(6) 2021, a 29mm tailor flexible annuloplasty band was implanted.On (b)(6) 2021, the patient presented with dyspnea and a pleural effusion was noted.The heart lung machine, procedure and overall patient condition (heart failure) caused the effusion.A pleural puncture was performed and the patient was reported to be in stable condition and since has been discharged.
Additional Manufacturer Narrative
Additional information: h6, h10 an event of elevated creatine, dyspnea and pleural effusion was reported.A more comprehensive assessment could not be performed as the device remains implanted was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: TAILOR FLEXIBLE ANNULOPLASTY BAND
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• MDR Report Key: 11664221
• Report Number: 2648612-2021-00038
• Device Sequence Number: 3015795
• Product Code: KRH
• UDI-Device Identifier: 05414734055697
• UDI-Public: 05414734055697
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K022363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2021

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: 05/09/2023
• Device Model Number: TAB-29
• Device Catalogue Number: TAB-29
• Device Lot Number: 6450139
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 04/14/2021
• Supplement Report FDA Received Date: 06/08/2021
• 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
• Patient Age: 77 YR
• Patient Weight: 49