MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM; VALVE REPAIR

Catalog Number UNK CDS

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

Patient Problems Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Sepsis (2067)

Event Date 10/04/2023

Event Type  Injury  

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.Based on available information, the cause of the reported patient effects (i.E., death, bleeding, stroke, myocardial infarction, sepsis/pneumonia) could not be determined as no case-specific information was available.The reported patient effects of death, hemorrhage, myocardial infarction, cerebrovascular accident, and septicemia as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported serious injury/ illness/ impairment was a 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 is estimated.D4: the udi number is not known as the part and lot numbers were not provided.D6: the implant date is estimated.The additional patient effect of death reported in the article are captured under a separate medwatch report.

Event Description

It was reported through a research article that 211 patients underwent transcatheter-edge-to-edge repair (teer) from june 2015 to may 2021.Within one year, the implanted mitraclip and implanted triclip may have caused or contributed to death, bleeding, stroke, myocardial infarction, sepsis/multiple organ dysfunction syndrome (mods), gastrointestinal bleeding, pneumonia, malignancy, recurrent tricuspid regurgitation (tr).Additional information is listed in the attached article, titled ¿impact of body mass index in patients with tricuspid regurgitation after transcatheter edge-to-edge repair.¿.

• Brand Name: MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
• 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: 18051828
• MDR Text Key: 327125939
• Report Number: 2135147-2023-04818
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100009
• 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: 11/01/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK CDS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2023
• Initial Date FDA Received: 11/01/2023
• 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: 78 YR
• Patient Sex: Female