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

Catalog Number CDS0601-XTR

Device Problem Migration (4003)

Patient Problems Dyspnea (1816); Mitral Regurgitation (1964); Swelling (2091); Tissue Damage (2104); Weakness (2145); Heart Failure (2206)

Event Date 10/10/2019

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 post procedure, patient was re-hospitalized due to partial clip movement with recurrent mr, tissue damage and heart failure.It was reported that the initial mitraclip procedure was performed on (b)(6) 2019 to treat functional mitral regurgitation (mr) with a grade of 4.One clip was implanted, reducing the mr to 2.On (b)(6) 2019, the patient was re-admitted due to heart failure symptoms; shortness of breath, exercise intolerance and swelling of extremities.On (b)(6) 2019, a transesophageal echocardiography (tee) was performed, which found mr had increased to 3-4.Bott leaflets remained inserted into the clip; however, the posterior clip arm had perforated through the posterior leaflet.The clip still remained attached and fixed to the valve, but tilted anteriorly and laying across the valve horizontally.The perforation was visible using 3d echocardiography which showed the perforation of the posterior leaflet was due to the clip arm.Mr is evident through the perforation and on medial and lateral to the clip.Due to co-morbidities, the patient will likely receive palliative care following conversation with patient and family.No additional information was provided.

Manufacturer Narrative

Exemption number e2019001-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 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 issue.Additionally, a review of the complaint history identified no similar incidents from the reported lot.Based on the information reviewed, a conclusive cause for the reported migration (partial clip movement) could not be determined.The reported tissue damage, recurrent mitral regurgitation, heart failure, dypsnea, swelling and physical weakness appear to be cascading effects of the reported migration (partial clip movement).The reported patient effects of mitral valve injury (tissue damage), worsening mitral regurgitation, worsening heart failure and dyspnea as listed in the mitraclip system instructions for use (ifu), are known possible complications associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9290867
• MDR Text Key: 165438360
• Report Number: 2024168-2019-13311
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648226366
• UDI-Public: 08717648226366
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 12/12/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/17/2020
• Device Catalogue Number: CDS0601-XTR
• Device Lot Number: 90618U191
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/18/2019
• Initial Date FDA Received: 11/07/2019
• Supplement Dates Manufacturer Received: 11/18/2019
• Supplement Dates FDA Received: 12/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization