MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP DELIVERY SYSTEM; VALVE REPAIR

Model Number CDS0601-NTR

Device Problem Incomplete Coaptation (2507)

Patient Problems Dyspnea (1816); Mitral Regurgitation (1964); Tissue Damage (2104); Atrial Perforation (2511)

Event Date 08/04/2020

Event Type  Injury  

Manufacturer Narrative

The clip remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report the single leaflet device attachment, recurrent mitral regurgitation, and ruptured chordae treated surgically.It was reported that this was a mitraclip procedure to treat grade 4 degenerative mitral regurgitation (mr).On (b)(6) 2020 one mitraclip was implanted reducing mr grade to 1.There were no adverse patient effects and no clinically significant delay in the procedure.On (b)(6) 2020 the patient was seen for a follow-up visit and was noted to have more shortness of breath.The echocardiogram showed a single leaflet device attachment of the mitraclip and two ruptured chordae.The posterior leaflet was no longer in the clip.The mitral valve had characteristic changes of myxomatous degeneration with annular and leaflet enlargement (carpentier classification ii).The patient underwent surgery to treat the mr.There was a large iatrogenic defect in the septum.There was no additional information 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 that would have contributed to this event and a review of the complaint history identified no similar incident reported from this lot.The reported patient effects of tissue damage, dyspnea, mr (mitral regurgitation) and atrial perforation, are listed in the mitraclip instructions for use as known possible complications associated with mitraclip procedures.Based on all available information, the reported slda (single leaflet device attachment) and poor imaging appear to be due to challenging patient anatomy.A cause for the reported tissue damage and atrial perforation could not be determined.The reported dyspnea and recurrent mr were cascading events of the reported tissue damage.There is no indication of a product issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10454853
• MDR Text Key: 204393594
• Report Number: 2024168-2020-07119
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648226342
• UDI-Public: 08717648226342
• Combination Product (y/n): N
• PMA/PMN Number: P100009
• 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: 09/24/2020

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 Expiration Date: 09/08/2020
• Device Model Number: CDS0601-NTR
• Device Catalogue Number: CDS0601-NTR
• Device Lot Number: 90907U179
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/04/2020
• Initial Date FDA Received: 08/26/2020
• Supplement Dates Manufacturer Received: 09/03/2020
• Supplement Dates FDA Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 88 YR
• Patient Weight: 37