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

Catalog Number UNK CDS

Device Problem Expulsion (2933)

Patient Problems Angina (1710); Bradycardia (1751); Dyspnea (1816); Myocardial Infarction (1969); Nausea (1970); Shock (2072); Diaphoresis (2452)

Event Date 03/01/2023

Event Type  Injury  

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 number regarding the complaint device was not provided.The investigation was unable to determine a cause for the reported expulsion.The reported angina, dyspnea, diaphoretic, nausea, shock, bradycardia, and myocardial infraction appear to be cascading effects of the expulsion.Angina, dyspnea, diaphoretic, nausea, shock, bradycardia, and myocardial infraction are listed in the instructions for use as known possible complications associated with mitraclip procedures.The reported delayed of treatment/ therapy, removal of foreign body in patient, unexpected medical intervention, medication required, hospitalization, and surgical intervention were results of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.The udi number is not known as the part and lot number were not provided.Attachment: article titled, "percutaneous retrieval of an embolized transcatheter mitral valve repair clip causing st-segment elevation myocardial infarction".

Event Description

This is filed to report clip embolization, causing patient effects, and intervention.It was reported in an article a mitraclip procedure was performed to treat a functional mitral regurgitation.The patient had a history of hypertension and hyperlipidemia.Evaluation for worsening exertional dyspnea over the prior year identified severe mitral valve regurgitation secondary to a flail p2 leaflet.Two clips were implanted with no reported issue.The patient tolerated the procedure well and was started on aspirin and clopidogrel.Eight days post procedure, the patient was presented by ambulance for a sudden-onset, crushing, left-sided chest pain associated with nausea, diaphoresis, and dyspnea.A repeat electrocardiogram obtained on arrival to the emergency department demonstrated st-segment elevation in the inferior leads with reciprocal st-segment depression in the lateral leads in the setting of ongoing chest pain.Angiography was performed, showing 1 clip in the aortic root, while the other remained attached to the mitral valve.The decision was made to attempt to snare the embolized clip to restore flow to the right coronary artery (rca).A 6-f 12- to 20-mm en snare endovascular snare system was deployed and successfully captured the clip for withdrawal into the abdominal aorta.The decision was made to upsize the right femoral artery (rfa) sheath to a 20-f gore dryseal flex introducer sheath to safely externalize the clip.Two perclose proglide devices were used to preclose the arteriotomy before upsizing the sheath.A 10-mm amplatz goose neck snare was then introduced via the 20-f rfa sheath to snare the clip for retrieval.The snare successfully captured the clip for retrieval through the 20-f rfa sheath.Following successful removal of the clip, the rfa sheath was withdrawn and the arteriotomy was closed with the existing closure devices.There were no postprocedural complications.The patient was discharged with plans for surgical mitral valve repair by his primary valve team.Details are listed in the attached article titled, "percutaneous retrieval of an embolized transcatheter mitral valve repair clip causing st-segment elevation myocardial infarction".

• 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: 16618472
• MDR Text Key: 312114551
• Report Number: 2135147-2023-01350
• 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: Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2023

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
• Initial Date Manufacturer Received: 03/02/2023
• Initial Date FDA Received: 03/27/2023
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male