MAUDE Adverse Event Report: ABBOTT VASCULAR SGC03; VALVE REPAIR

Catalog Number SGC0302

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Heart Failure (2206); Atrial Perforation (2511)

Event Date 06/25/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The investigation was unable to determine a conclusive cause for the atrial perforation and heart failure.The reported patient effects of atrial perforation and heart failure are listed in the mitraclip nt system instructions for use as known possible complications associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design, or labeling.

Event Description

This is filed to report an atrial perforation and heart failure.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.One clip was successfully implanted, reducing mr to a grade of 1.However, after the clip was implanted, a left to right shunt was observed that possibly worsened right sided heart failure.For treatment, a closure device was implanted.There was no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: SGC03
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 10284934
• MDR Text Key: 199138874
• Report Number: 2024168-2020-05901
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2021
• Device Catalogue Number: SGC0302
• Device Lot Number: 00113U116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Weight: 44