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

Catalog Number CDS0502

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Hemorrhage/Bleeding (1888); Mitral Regurgitation (1964); Neurological Deficit/Dysfunction (1982); Tissue Damage (2104)

Event Date 12/06/2019

Event Type  Death  

Manufacturer Narrative

Exemption number e201900.The device remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional mitraclip device referenced is being filed under a separate medwatch report.

Event Description

This is filed to report tissue damage.It was reported that this was mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+.While moving the clip delivery system (cds) (90629u133) to the operating table, it came in contact with one of the operator¿s goggles, rendering the device unsterile.A second cds (90629u171) was prepped and inserted.Grasping was performed and noted to be difficult.The mr was successfully reduced; however, the preexisting flail was still partially present.Therefore, the clip was repositioned.After regrasping, mr did not reduce.It was then confirmed that the posterior leaflet was cut.The clip was repositioned again, and mr reduced to a grade of 3.A third clip (90701u144) was advanced and placed medially of the implanted clip.Grasping was performed and noted to be difficult.The mr became uncontrollable and increased to 4+.The clip was retracted into the left atrium and the echocardiologist determined that torn leaflet could not be fixed with the mitraclips.At this point it was realized that the root of the posterior leaflet was cut from the medial to center portion.The physician stated that the tear occurred after the first clip was implanted and was worsened by the second clip.To treat mr and the cut leaflet, the physician decided to perform a mitral valve replacement.There was no clinically significant delay in the procedure.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 revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents reported from this lot.The reported patient effects of mitral regurgitation (mr), tissue damage, death, neurological deficit/dysfunction and hemorrhage, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The investigation determined the reported difficult or delayed positioning (leaflet grasping) appears to be related to patient morphology/pathology.The patient effects of mr, tissue damage, death, neurological deficit/dysfunction and hemorrhage were results of procedural conditions.There is no indication of a product issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the initially filed report, the following information was received: on (b)(6) 2019, the patient passed away due to hypoxic encephalopathy, because hemorrhage was too much due to the prolonged surgical 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
• MDR Report Key: 9503611
• MDR Text Key: 174363932
• Report Number: 2024168-2019-14838
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/06/2020

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: 06/30/2020
• Device Catalogue Number: CDS0502
• Device Lot Number: 90629U171
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 12/19/2019
• Supplement Dates FDA Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER
• Patient Outcome(s): Death; Hospitalization; Required Intervention; Disability
• Patient Age: 44 YR
• Patient Weight: 58