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

Catalog Number CDS0602-NTR

Device Problems Failure To Adhere Or Bond (1031); Difficult to Remove (1528)

Patient Problem Tissue Damage (2104)

Event Date 05/22/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The mitraclip ntr is currently not commercially available in the us; however, it is similar to a device sold in the us.The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The additional mitraclip xtr device is being filed under separate medwatch report.

Event Description

This is filed to report the difficult to remove and leaflet tear with the clip delivery system (cds 80115u245).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 that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot specific product quality issue.All available information was investigated and the reported physical resistance appears to be due to user technique/procedural conditions as the device interacted with the anatomy while positioning was performed.The reported tissue damage appears to be due to physical resistance as the choral rupture was noted to the posterior mitral valve leaflet (pml).The reported failure to adhere or bond appears to be due to the noted choral rupture that resulted in flail pml.It should be noted that the reported patient effect of mitral valve injury (tissue damage) is listed in the mitraclip system instructions for use as a 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.

• Brand Name: MITRACLIP NTR 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: 7592280
• MDR Text Key: 110785881
• Report Number: 2024168-2018-04401
• 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: 01/15/2019
• Device Catalogue Number: CDS0602-NTR
• Device Lot Number: 80115U245
• 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: 07/26/2018
• 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): Required Intervention