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); Incomplete Coaptation (2507)

Patient Problems Dyspnea (1816); Mitral Regurgitation (1964); Tissue Damage (2104)

Event Date 02/21/2018

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 additional relevant information.

Event Description

This is filed to report the single leaflet device attachment (slda).It was reported that the initial mitraclip procedure was performed on (b)(6) 2017 to treat functional mitral regurgitation (mr) with an unspecified mr grade.Two clips (70916u159, 70919u148) were implanted, there was difficulty grasping the leaflets with one of the clips.(it is unknown which clip had the diffculty grasping).Mr was reduced to an unspecified mr grade.On (b)(6) 2018, the patient returned experiencing dyspnea, echocardiography was performed, which found that one clip had detached from the posterior leaflet and remained attached to the anterior leaflet (slda).Tissue damage was noted on the posterior leaflet, likely due to the difficulty grasping during the intial procedure.It is unknown which clip had the slda, 70916u159 or 70919u148.Mr grade was 3-4.On (b)(6) 2018, an additional mitraclip procedure was performed.One clip was implanted reducing mr to 2-3.The patient is stable.No other information was provided.

Manufacturer Narrative

(b)(4).Although the clip that experienced the single leaflet device attachment could not be identified, the expiration date of each of the two implanted clips are: lot number 70916u159 expiration date: 09/16/2018; lot number 70919u148 expiration date: 09/19/2018.The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.All available information was investigated and the reported single leaflet device attachment (slda)in this incident appears to be related to patient morphology/challenging anatomy (pre-existing thin and damaged posterior mitral valve leaflet).A definitive cause for the reported failure to adhere/ bond (difficult grasping the leaflet) could not be determined.The reported worsening mitral regurgitation (mr) was likely a result of patient/procedural conditions due to the slda; the reported dyspnea (shortness of breath) was symptom related to increased mr and slda and tissue damage was a result of procedural circumstances of the initial procedure and difficulties with leaflet grasping.It should be noted that the reported patient effects of shortness of breath(dyspnea), worsening mr, mitral valve injury (tissue damage), are listed in the mitraclip system instructions for use as known possible complications 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 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: 7359098
• MDR Text Key: 103109322
• Report Number: 2024168-2018-02045
• 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: 06/05/2018

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 Catalogue Number: CDS0502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2018
• Initial Date FDA Received: 03/21/2018
• Supplement Dates Manufacturer Received: 05/31/2018
• Supplement Dates FDA Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2017
• 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
• Treatment: IMPLANTED MITRACLIP (X1)
• Patient Outcome(s): Hospitalization; Required Intervention