MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP® SYSTEM STEERABLE GUIDE CATHETER; VALVE REPAIR

Catalog Number UNK SGC

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

Patient Problem Perforation (2001)

Event Date 01/09/2024

Event Type  Injury  

Event Description

It was reported through a research article that 100 patients underwent transcatheter edge-to-edge repair (teer) from (b)(6) 2020 to (b)(6) 2021.Within one year of the procedure, the steerable guide catheter may have caused or contributed to a right to left shunt.Additional information is listed in the attached article, titled ¿mitral valve gradient changes associate with outcomes of patients undergoing transcatheter edge-to-edge repair.¿.

Manufacturer Narrative

The device was not returned for analysis.The lot history record (lhr) review was not performed because this incident was based on an article review and no lot information was provided.Additionally, the complaint history review was not performed because this incident was based on an article review and no lot information was provided.Based on available information and due to the limited information available from the article, the cause of the reported perforation was unable to be determined.The reported patient effect of perforation as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported serious injury/ illness/ impairment was the result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.B3: date of event estimated d4: the udi is unknown due to the part/lot number was not provided attachment: article titled ¿mitral valve gradient changes associate with outcomes of patients undergoing transcatheter edge-to-edge repair.

• Brand Name: MITRACLIP® SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18563284
• MDR Text Key: 333469062
• Report Number: 2135147-2024-00322
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K112239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SGC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 79 YR
• Patient Sex: Female