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

Catalog Number CDS0502

Device Problems Failure To Adhere Or Bond (1031); Entrapment of Device (1212)

Patient Problems Tissue Damage (2104); Foreign Body In Patient (2687)

Event Date 03/14/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).As the patients blood pressure continued to drop, the decision was made to implant the clip on the anterior mitral leaflet.A chordal rupture of the anterior mitral leaflet was noted.The patient was then converted to a surgical procedure.Three small holes were noted in the roof of the left atrium, thought to be likely caused by the extra stiff guide wire.The clip was noted to be attached to the anterior mitral leaflet and chordae and was explanted.The first implanted clip was noted to be well attached to both leaflets and was left in place.An annuloplasty ring was implanted.The post procedure mr grade was less than 1.Post procedure, the patient was hemodynamically stable.No additional information was provided.The device was not returned.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

This event is filed for entrapment, causing tissue damage, and surgical intervention.It was reported that on (b)(6) 2018, the patient, with functional mitral regurgitation (mr), underwent a mitraclip procedure.The steerable guide catheter (sgc) and the clip delivery system (cds) were advanced into the left atrium without issue.Care was taken to not touch any tissue in the left atrium.The clip was steered down to the mitral valve and a pericardial effusion was noted on echocardiogram which was reportedly due to an unspecified guide wire which was super stiff.The physician performed a pericardiocentesis, which worked well to treat the pericardial effusion.The mitraclip procedure continued and the clip was placed at the anterior 2/posterior 2 (a2/p2) leaflet segment.The clip was deployed without issue and the mr grade was reduced from 3-4 to 2.It was decided to implant a second clip (71204u129), medial to the first, to treat a residual jet.The second clip was inserted and steered down to the mitral valve without issue.Care was taken to not touch any tissue in the left atrium.The clip was positioned in the left atrium, closed and advanced into the left ventricle.The clip was opened and grasping was initiated.The clip was unable to grasp the posterior leaflet.The pericardial bleeding had not stopped and the patient's blood pressure dropped.The physician decided to abort the procedure and the clip was inverted.An attempt was made to retract the clip into the left atrium; however, the clip became caught under the anterior mitral leaflet in the chordae.

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 the reported event.Additionally, a review of the complaint history identified no similar incidents reported from this lot.The reported patient effect of mitral valve injury (tissue damage) as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.All available information was investigated, and the reported entrapment of device component appears to be related to the operational context (inverted clip).A definitive cause for the reported failure to bond (difficulty grasping the leaflets) could not be determined.The reported tissue damage was a result of chordal entanglement.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 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
• 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: 7396747
• MDR Text Key: 104363094
• Report Number: 2024168-2018-02464
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/18/2018

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: 12/05/2018
• Device Catalogue Number: CDS0502
• Device Lot Number: 71204U129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2018
• Initial Date FDA Received: 04/04/2018
• Supplement Dates Manufacturer Received: 06/13/2018
• Supplement Dates FDA Received: 06/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MITRACLIP (PART# CDS0502, LOT# 71204U102)
• Patient Outcome(s): Required Intervention