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); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer reported the clip remians implanted and the mitraclip delivery system was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report clip movement and single leaflet device attachment (slda).It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.The first mitraclip delivery system (cds) was successfully implanted medial.A second cds was advanced to the mitral valve, however, when going from the left atrium to the left ventricle, the clip got caught in the chordae, troubleshooting maneuvers were performed to free the clip from the chordae and the leaflets were successfully grasped.During clip deployment, when the clip released from the mandrel, there was tension on the clip, resulting in partial clip movement but the clip remained on both leaflets.Mr was reduced to 2-3.Fifteen minutes after clip deployment of the second clip, it was noted that the second clip detached from the posterior leaflet, and remained attached to the anterior leaflet (slda).Mr increased to 3-4.A third clip was implanted to further reduce mr and to stabilize the second clip; reducing mr to 2.The patient is stable.There were no adverse patient effects and there was no clinically significant delay in the procedure.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 the reported event.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.All available information was investigated, and the reported partial clip movement, single leaflet device attachment (slda) and physical resistance appear to be related to user technique/procedural circumstances.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: 7338347
• MDR Text Key: 102365271
• Report Number: 2024168-2018-01816
• 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: 05/31/2018

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: 09/23/2018
• Device Catalogue Number: CDS0502
• Device Lot Number: 70922U248
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2018
• Initial Date FDA Received: 03/14/2018
• Supplement Dates Manufacturer Received: 05/23/2018
• Supplement Dates FDA Received: 05/31/2018
• 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: STEERABLE GUIDE CATHETERIMPLANTED MITRACLIP (X1)
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR