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

Model Number N/A

Device Problem Expulsion (2933)

Patient Problems Unspecified Infection (1930); Myocardial Infarction (1969); Pain (1994); Sepsis (2067); Numbness (2415); Foreign Body In Patient (2687); Embolism/Embolus (4438)

Event Date 08/22/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Date of event: dates estimated the udi number is not known as the part and lot number were not provided.

Event Description

This is filed to report clip detachment and embolization requiring intervention.It was reported that a patient underwent a mitraclip procedure on an unknown date and two mitraclips were implanted.Two weeks post procedure, one of the clips detached from the valve and embolized causing a myocardial infarction.The patient required surgery, and physicians were able to locate and remove the embolized clip.After the retrieval surgery, the patient developed a staph infection, which eventually led to sepsis.An additional surgery was required to remove the origin of the staph infection coupled with a five week regimen of antibiotics.It was noted that once the patient infection was cleared, they would undergo open chest surgery to replace their mitral valve.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis and a review of the lot history record and similar complaint review could not be performed as the part and lot information regarding the complaint device was not provided.All information was investigated and due to limited information provided by the account, a cause for the expulsion cannot be determined.Based on the information reviewed, the reported foreign body in patient and embolism resulting in myocardial infarction appear to be related clip completely detaching from both the leaflets (expulsion).Staph infection, sepsis, numbness and pain appears to be due to the surgeries.Emboli, foreign body in patient (dislodgement of previously implanted devices), pain, myocardial infarction, infection and sepsis are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.The reported surgical intervention, removal of foreign body, medication required and hospitalization were a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.B3: date estimated.D4: the udi number is not known as the part and lot number were not provided.

• 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: 15418957
• MDR Text Key: 299871257
• Report Number: 2135147-2022-01193
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/14/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNK CDS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2022
• Initial Date FDA Received: 09/14/2022
• Supplement Dates Manufacturer Received: 11/02/2022
• Supplement Dates FDA Received: 11/14/2022
• 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
• Treatment: 1 IMPLANTED MITRACLIP
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male