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

Model Number CDS0601-NTR

Device Problem Incomplete Coaptation (2507)

Patient Problems Death (1802); Dyspnea (1816); Edema (1820); Mitral Regurgitation (1964); Tissue Damage (2104)

Event Date 05/18/2020

Event Type  Death  

Manufacturer Narrative

The clip remains in the patient.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 patient death, suspected leaflet tear/single leaflet device attachment.It was reported that on (b)(6) 2020 the patient with grade 4 functional mitral regurgitation underwent the mitraclip procedure in the patient who was already in pre-existing cardiogenic shock and on a balloon pump.Three mitraclips were implanted reducing mr grade to 2.On (b)(6) 2020 the patient underwent a redo mitraclip procedure for symptomatic (shortness of breath and edema) recurrent grade 4 mr.Although the three clips were stable on the leaflets, there was mr coming through the lateral side, where the third clip was implanted.It is suspected that the posterior leaflet is still attached to the mitraclip, but the posterior leaflet may have torn.This was considered a single leaflet device attachment.The redo clip procedure was not successful, so the patient underwent a surgical mitral valve replacement on (b)(6) 2020.After the surgery, the patient required extracorporeal membrane oxygenation (ecmo) support.While the patient was on ecmo, a thrombus occurred and the patient expired on (b)(6) 2020.The thrombus was due to the patient being on ecmo.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported issue.Additionally, a review of the complaint history identified no other incidents reported from this lot that would have contributed to this event.Based on the information reviewed, a conclusive cause for slda (single leaflet device attachment) could not be determined.The reported mr (mitral regurgitation) and tissue damage were outcomes of the slda.The reported patient death was due to procedural conditions.A conclusive cause for edema and dyspnea could not be determined.The reported patient effects of mr, death, dyspnea, tissue damage, and edema as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedure.There is no indication of a product issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP NTR CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10124070
• MDR Text Key: 194162394
• Report Number: 2024168-2020-04778
• 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: 08/25/2020

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: 10/13/2020
• Device Model Number: CDS0601-NTR
• Device Catalogue Number: CDS0601-NTR
• Device Lot Number: 91014U280
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/18/2020
• Initial Date FDA Received: 06/05/2020
• Supplement Dates Manufacturer Received: 07/31/2020
• Supplement Dates FDA Received: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2 OTHER MITRACLIPS; 2 OTHER MITRACLIPS
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 68