MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT; MITRACLIP DELIVERY SYSTEM

Catalog Number CDS0501

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Arrhythmia (1721); Death (1802); Low Blood Pressure/ Hypotension (1914); Mitral Regurgitation (1964); Tissue Damage (2104); Cardiogenic Shock (2262); Respiratory Failure (2484)

Event Date 05/04/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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 tissue damage,worsening mitral regurgitation, cardiogenic shock and death.It was reported that this was a mitraclip procedure to treat a mixed mitral regurgitation (mr) with multiple jets, possible pseudo cleft and grade of 4+.The first clip (70726u277) was implanted at a2/p2.The mr remained at 4+, with a lateral jet remaining.The second clip (70822u160) was placed lateral to a1/p1; however, grasping was difficult due to the leaflet anatomy.The clip was repositioned and multiple grasping attempts were made.It was believed that there was possible tearing of the valve or chordae.The clip was deployed lateral to a2/p2 and the mr was reduced to 3-4.The procedure was discontinued.One day after the procedure, the patient expired due to cardiogenic shock and worsening mr.In the physicians opinion, the procedure was long and possible tearing of valve or cords could have caused or contributed to the patient death.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported.Additionally, a review of the complaint history identified no similar incidents reported from this lot.All available information was investigated and the reported difficulty grasping appears to be related to patient morphology/pathology (cleft/fold).The reported death was due to the cardiogenic shock, worsening mitral regurgitation (mr), and the long and complex procedure, but not directly related to the device.The worsening mr was due to the procedural conditions of difficulty grasping and possible tearing of the valve /chordae.The reported tissue damage appears to be related to procedural circumstances of the difficult grasping; however, a definitive cause for the cardiogenic shock was undetermined.The reported patient effects of death, worsening mr, tissue damage and cardiogenic shock, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.This event was further reviewed by an abbott vascular medical affairs director.The reviewer concluded that the death was related to the procedure which was long and complex, but not directly related to the device which exhibited no malfunction.

Event Description

Subsequent to the previously filed report, the following information pertaining to this event was obtained from article title, percutaneous edge-to-edge mitral valve repair: navigating the challenges of multiple mechanisms for mitral regurgitation.The is a case presentation of an 83-year-old male patient whom underwent a mitraclip procedure to treat mitral regurgitation (mr) with an mr grade of 4.The first clip was implanted, reducing mr to 3-4.A second clip delivery system (cds 70822u160) was advanced.Grasping was difficult due to a pre-existing cleft on the posterior leaflet.The clip was implanted and a large residual jet was seen between the two clips.The patient developed decompensated heart failure, atrial fibrillation requiring electrical cardioversion.The patient was stabilized with medication.A third cds was advanced, but the leaflets could not be grasped, and a chordae flail was noted.The mr returned to 4.The third clip was not implanted and was removed.The patient at this point had worsening hypoxemia and hypotension requiring medication, a balloon pump was placed, the patient went into cardiogenic shock and the patient passed away the following day.No additional information was provided.

Manufacturer Narrative

(b)(4).The clip remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT
• Type of Device: MITRACLIP DELIVERY SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7561418
• MDR Text Key: 109812707
• Report Number: 2024168-2018-04059
• Device Sequence Number: 1
• Product Code: NKM
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/27/2019

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 Expiration Date: 08/22/2018
• Device Catalogue Number: CDS0501
• Device Lot Number: 70822U160
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/10/2018
• Initial Date FDA Received: 06/01/2018
• Supplement Dates Manufacturer Received: 08/21/2018; 06/03/2019
• Supplement Dates FDA Received: 08/27/2018; 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2 IMPLANTED MITRACLIP; STEERABLE GUIDE CATHETER 1 IMPLANTED MITRACLIP; STEERABLE GUIDE CATHETER ONE (1) IMPLANTED MITRACLIP
• Patient Outcome(s): Death
• Patient Age: 83 YR