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

Catalog Number CDS0501

Device Problems Failure To Adhere Or Bond (1031); Knotted (1340); Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/27/2018

Event Type  Injury  

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 relevant information.

Event Description

This is filed to report the clip opened during deployment.It was reported that on (b)(6) 2018, the patient, with degenerative mitral regurgitation, underwent a mitraclip procedure.The clip delivery system (cds) was advanced into the patient anatomy without difficulty and the clip was placed on the mitral leaflets, at the anterior 2/posterior 2 (a2/p2) leaflet segments.Mr was reduced from grade 4 to trace.Clip deployment was initiated.The lock was checked and the lock lines were unwrapped.A knot was noted in the lock line and was cut.The lock line was removed.The release pin was removed and the actuator knob was rotated 8 times.It was noted that the clip popped open about 90-100 degrees, but remained on the leaflet.There was some clip movement noted and mr increased from trace to grade 1.The decision was made to implant a second clip, as close as possible to the first clip, to stabilize the first clip.A second clip was implanted without issue, lateral to the first, and stabilizing the first clip.No clip movement was noted and mr was reduced to trace.Post procedure, the patient was in stable condition, with both clips attached to both leaflets.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 contributed to the event.Additionally, a review of the complaint history identified no other incidents reported from this lot.All available information was investigated and a definitive cause for the reported knot on the lock line, mechanical issue-clip open while locked and partial clip movement could not be determined.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: 7442101
• MDR Text Key: 105873720
• Report Number: 2024168-2018-02902
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/06/2018
• Device Catalogue Number: CDS0501
• Device Lot Number: 71104U117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Weight: 50