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 No Consequences Or Impact To Patient (2199)

Event Date 05/02/2018

Event Type  malfunction  

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 partial clip movement.It was reported that this was a mitraclip procedure to treat grade 3 to 4 mixed etiology mitral regurgitation (mr).The first mitraclip was implanted without issue.After the second mitraclip was deployed there appeared to be more movement on the first mitraclip under x-ray imaging.The two devices did not touch nor did they interact with each other.It is suspected that there was a cleft on the posterior leaflet where the first clip was moving slightly.It is suspected that the first clip moved slightly from the original location on the leaflet, but both leaflets remain inside the mitraclip.The procedure was completed with mr grade 1 to 2.There were no adverse patient effects and no clinically significant delay in the procedure.There was no additional information 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 clip movement appears to be related to patient morphology/pathology (pre-existing posterior leaflet cleft).There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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
• MDR Report Key: 7539323
• MDR Text Key: 109382992
• Report Number: 2024168-2018-03883
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/22/2018
• Device Catalogue Number: CDS0501
• Device Lot Number: 71122U146
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/02/2018
• Initial Date FDA Received: 05/23/2018
• Supplement Dates Manufacturer Received: 07/05/2018
• Supplement Dates FDA Received: 07/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OTHER MITRACLIP, STEERABLE GUIDE CATHETER
• Patient Age: 75 YR
• Patient Weight: 79