MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM; VALVE REPAIR

Catalog Number CDS0602-XTR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aneurysm (1708); Mitral Regurgitation (1964)

Event Date 08/06/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number (b)(4) -permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.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 being filed to report that after the initial procedure, the patient had recurrent mitral regurgitation.It was reported that the initial mitraclip procedure was performed on (b)(6) 2019 to treat a functional mitral regurgitation (mr) with grade of 4+.Prior to the procedure, there was a heart team meeting to decide if the patient should have surgery or the mitraclip procedure.It was decided to perform the mitraclip procedure.Two clips were implanted reducing mr to 3 and the physician decided to stop with mr grade of 3.On (b)(6) 2019, while still in the hospital the mr increased.The clips were confirmed to be stable on both leaflets.Reportedly, the patient had chronic obstructive pulmonary disease (copd) and the physician thought the patient had an aneurysm.The patient was treated with surgery on the same day.No additional information was provided.

Manufacturer Narrative

Exemption number e2019001.(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.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.The reported patient effects of worsening mitral regurgitation as listed in the mitraclip system instructions for use (ifu), is a known possible complication associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Additional information received reporting that the aneurysm was pre-existing and did not occur during the procedure.No additional information was provided.

• Brand Name: MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 8940273
• MDR Text Key: 155988772
• Report Number: 2024168-2019-11259
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/07/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/05/2020
• Device Catalogue Number: CDS0602-XTR
• Device Lot Number: 90606U185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/06/2019
• Initial Date FDA Received: 08/28/2019
• Supplement Dates Manufacturer Received: 09/24/2019
• Supplement Dates FDA Received: 10/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2019
• 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