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

Catalog Number CDS0602-XTR

Device Problems Failure To Adhere Or Bond (1031); Incomplete Coaptation (2507)

Patient Problems Death (1802); Mitral Regurgitation (1964); Heart Failure (2206)

Event Date 05/22/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The mitraclip xtr is currently not commercially available in the us; however, it is similar to a device sold in the us.The clip remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The additional mitraclip ntr device referenced in describe event or problem is being filed under separate medwatch report.

Event Description

This is filed to report the patient death that occurred after use with the clip delivery system (cds 80119u142).It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.The first mitraclip ntr cds (80115u262) was advanced to the mitral valve.The clip was implanted, reducing mr to 3.A second mitraclip ntr cds (80115u245) was advanced; however, when positioning the clip, the clip got stuck in the chordae.Troubleshooting was performed and the clip was freed; however, a chordal rupture occurred creating a posterior leaflet flail.The mr returned to 4.Grasping attempts were performed, but unsuccessful due to the anatomy.The clip was not implanted and the cds was removed.A mitraclip xtr cds (80119u142) was advanced to treat the chordae rupture/ leaflet flail; however, grasping was unsuccessful due to the anatomy.The decision was made deploy the clip close to the commissure, reducing mr to 3-4.After deployment, the clip detached from the anterior leaflet, and remained attached to the posterior leaflet (single leaflet device attachment/slda), and the mr returned to 4.There was less left ventricular ejection fraction caused by the severity of mr; therefore, an impella heart pump was placed.The patient was scheduled for mitral valve replacement on (b)(6) 2018; however, the patient died on (b)(6) 2018 due to heart decompensation and multi-organ dysfunction.Per the physicians opinion, the flail in combination with the slda caused 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 lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents reported from this lot.All available information was investigated and the reported failure to adhere or bond and single leaflet device attachment (slda) appears to be due to patient morphology/pathology.The reported unchanged mitral regurgitation (mr) appears to be due to slda.The reported heart failure appears to be related to procedural circumstances; however, the death was due to heart compensation and multi-organ failure.It should be noted that the reported patient effects of death, mr and heart failure are listed in the mitraclip system instructions for use, as known possible complication associated with mitraclip procedures.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacturing, or labeling of the device.This incident was further reviewed by an abbott vascular medical affairs director and the reviewer stated that a cascade of events related to the user technique led to prolonged procedure and persistent mr leading to cardiac decompensation and ultimately death.

• Brand Name: MITRACLIP XTR DELIVERY SYSTEM
• Type of Device: MITRACLIP DELIVERY SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): MENLO PARK, CA REG# 3005070406; abbott vascular; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 7592351
• MDR Text Key: 110781800
• Report Number: 2024168-2018-04402
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/02/2018

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: 01/19/2019
• Device Catalogue Number: CDS0602-XTR
• Device Lot Number: 80119U142
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2018
• Initial Date FDA Received: 06/12/2018
• Supplement Dates Manufacturer Received: 07/30/2018
• Supplement Dates FDA Received: 08/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2018
• 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
• Treatment: IMPLANTED MITRACLIP(X1)STEERABLE GUIDE CATHETER
• Patient Outcome(s): Death