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

Catalog Number CDS0501

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Tissue Damage (2104)

Event Date 12/21/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer reported the clip delivery system was discarded and the clip remains implanted.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The other clip delivery system (70829u192) is filed under a separate medwatch report.

Event Description

This is filed for the possible leaflet damage.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4 and a flailed chord at a1/p1.The first clip delivery system (cds 70829u182) was advanced to the mitral valve.Grasping was noted to be difficult; however, a good grasp was achieved with mr reduction to 1+.After clip deployment, the mr increased to 3-4 and it was observed that a piece of the a1 leaflet was flipping up in the left atrium.It was inconclusive if the anterior leaflet was torn or if there was a poor grasp; however, because the clip was stable, it was believed that there was tissue damage.The second cds (70829u192) was advanced and grasping was attempted in multiple locations, but the mr could not be reduced.The cds was removed and the second clip was not implanted.After removal, there appeared to be a piece of chordae in the clip arms and some mr was observed at a2/p2.It was believed that this may have been caused by the clip arms.Additionally, it was noted that imaging was challenging during the procedure.The patient was confirmed to be stable post procedure, and was treated medically.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 identified no similar incidents from the lot.The reported patient effects 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 difficulty grasping the leaflets appears to be related to patient morphology/pathology.The reported patient effect of tissue damage appears to be related to procedural circumstances of difficult grasping.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: 7190844
• MDR Text Key: 97360967
• Report Number: 2024168-2018-00376
• 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: 04/17/2018

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: 08/29/2018
• Device Catalogue Number: CDS0501
• Device Lot Number: 70829U182
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2017
• Initial Date FDA Received: 01/15/2018
• Supplement Dates Manufacturer Received: 04/08/2018
• Supplement Dates FDA Received: 04/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2017
• 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: 80 YR
• Patient Weight: 78