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 Mitral Regurgitation (1964)

Event Date 05/16/2018

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 suspected partial clip movement and recurrent mitral regurgitation.It was reported that on (b)(6) 2018 this was a mitraclip procedure to treat grade 4 degenerative mitral regurgitation (mr).It was a straightforward case where a single mitraclip was successfully implanted reducing mr to grade 1.On (b)(6) 2018 a re-clip procedure was performed for recurrent mr grade 4.The original clip was attached to both leaflets; however, the clip was not how they left it in march.The original clip was suspected to have moved from its original location on the leaflets.Two additional mitraclips were implanted reducing mr to grade 1.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 this event.Review of the complaint history identified no similar incidents reported from this lot.A definitive cause for the failure to adhere or bond (partial clip movement) in this incident could not be determined.It is possible that the patient conditions contributed to the reported issue, however, this cannot be confirmed.The recurrent mr was due to the partial clip movement.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
• 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: 7571692
• MDR Text Key: 110166235
• Report Number: 2024168-2018-04171
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/23/2018

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: 07/24/2018
• Device Catalogue Number: CDS0501
• Device Lot Number: 70721U128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2018
• Initial Date FDA Received: 06/05/2018
• Supplement Dates Manufacturer Received: 08/17/2018
• Supplement Dates FDA Received: 08/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 86 YR
• Patient Weight: 62