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

Catalog Number CDS0602-XTR

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

Patient Problems Anemia (1706); Cardiac Enzyme Elevation (1838); No Consequences Or Impact To Patient (2199); Heart Failure (2206)

Event Date 12/31/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The mitraclip remains in the patient.Investigation is not complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This report is filed for hospitalization for heart failure.It was reported that on (b)(6) 2018, a mitraclip procedure was performed without reported issues for degenerative mitral regurgitation (mr) grade 4+.Unspecified clip (s) were implanted without a device issue reported.On (b)(6) 2018, the mr was noted at grade 2.On (b)(6) 2018, the patient was hospitalized for heart failure, anemia, and elevated troponin, unknown if related to the device.Necrobiosis lipoidica was also suspected.As treatment, a blood transfusion and medication was provided.On (b)(6) 2019, the mr was reported as grade 4+.Per physician, the increase was unrelated to the device.No additional information was provided regarding this issue.

Manufacturer Narrative

Patient codes: 2199 labeled na.Internal file number - (b)(4).Patient codes 1706, 1838, and 2206 removed.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other incidents.It should be noted that the reported patient effect of worsening mitral regurgitation (mr), as listed in the mitraclip system instructions for use is a known possible complication associated with mitraclip procedures.Based on the information reviewed, the reported mr appears to be related to case circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.Subsequent to the initial mdr submitted, additional information received that the patient effects were unrelated to the implanted mitraclip.Based on the new information, this event would not be mdr reportable.

Event Description

Subsequent to the previous report filed, additional information was obtained: on (b)(6) 2018, one mitraclip (cds0602-xtr, lot 80912u111) was implanted, reducing the mitral regurgitation (mr) from grade 4+ to 0-1.Reportedly, the increase in mr, noted on 12/31/2018, was due to disease progression, unrelated to the device.The clip remained stable and well seated on the leaflets.According tot he physician, there is no clinical indication that the heart failure and anemia are device related.Based on this new information this event would not be medwatch reportable.

• Brand Name: MITRACLIP XTR DELIVERY SYSTEM
• Type of Device: MITRACLIP DELIVERY SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8306427
• MDR Text Key: 135052266
• Report Number: 2024168-2019-00833
• 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: foreign,health professional,s
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/21/2019

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: 09/24/2019
• Device Catalogue Number: CDS0602-XTR
• Device Lot Number: 80912U111
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/14/2019
• Initial Date FDA Received: 02/05/2019
• Supplement Dates Manufacturer Received: 02/06/2019
• Supplement Dates FDA Received: 02/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Weight: 59