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

Model Number SGC0301

Device Problems Difficult to Remove (1528); Physical Resistance/Sticking (4012)

Patient Problem Atrial Perforation (2511)

Event Date 11/04/2020

Event Type  Injury  

Manufacturer Narrative

The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The additional mitraclip delivery system referenced is filed under a separate medwatch report number.

Event Description

This is filed to report atrial perforation, tissue damage, difficult to remove.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.The steerable guide catheter (sgc) was advanced to the mitral valve, and the first clip was deployed, reducing mr.Then a second clip delivery system (cds) was advanced to the mitral valve; however, the septum tore causing the sgc to lose height.Then the cds dropped below the valve, and the clip became entangled with the chordae.After maneuvering, the clip became freed, but a chordal rupture occurred.A decision was made to remove the sgc and cds from the patient to abort the procedure.After the cds was removed, it was noted that the actuator mandrel was protruding distally.Additional treatment was not performed.The patient is stable.One clip was implanted, reducing mr to 3.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no other complaint reported from this lot.All available information was investigated and the reported physical resistance appears to be due to procedural circumstances/operational context and a conclusive cause for atrial perforation and difficult to remove could not be determined.The reported patient effect of atrial perforation (cardiac perforation) as listed in the mitraclip system instructions for use (ifu), is a known possible complication associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the initial report, the following information was provided: during retraction of the clip delivery system (cds), some resistance was felt.No additional information was provided.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10900244
• MDR Text Key: 218242038
• Report Number: 2024168-2020-09898
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648216824
• UDI-Public: 08717648216824
• Combination Product (y/n): N
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/12/2021
• Device Model Number: SGC0301
• Device Catalogue Number: SGC0301
• Device Lot Number: 00612U112
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1 IMPLANTED MITRACLIP; CLIP DELIVERY SYSTEM; 1 IMPLANTED MITRACLIP; CLIP DELIVERY SYSTEM
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 63