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

Catalog Number CDS0502

Device Problem Incomplete Coaptation (2507)

Patient Problems Stroke/CVA (1770); Hemolysis (1886); Tachycardia (2095); Tissue Damage (2104)

Event Date 05/25/2020

Event Type  Injury  

Manufacturer Narrative

The clip was explanted and will not be returning.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 single leaflet device attachment (slda).It was reported that this was a mitraclip procedure performed to treat grade 4 degenerative mitral regurgitation (mr).The first clip was implanted in a3/p3; however, the clip detached from the anterior leaflet and remained attached to the posterior leaflet (slda) and anterior leaflet injury occurred.A second clip was implanted medial to the first clip, stabilizing the slda clip.Mr was reduced to 3+.Post clip implantation, the patient experienced several complications (embolic disease, hemolytic anemia, hypokalemia resulting in torsades de pointes).On (b)(6) 2020, mitral valve replacement surgery was performed.On (b)(6) 2020, the patient was in stable condition.The symptoms of embolic disease resolved and the patient was in physical therapy for walking.No additional information was provided.

Event Description

Subsequent to the initially filed report, the following information was received: postoperative day one, of the mitraclip procedure; the embolic disease occurred, and bilirubin increased, (symptom of cerebral infarction).Postoperative day two, hemolytic anemia was diagnosed.Postoperative day three, torsades de pointes (tdp) occurred.Hemolytic anemia and tdp recovered through a surgical procedure.The patient got well and was discharged.In the physician¿s opinion, the mitraclip did not cause or contribute to the embolic disease.However, there is a possibility the mitraclip caused or contributed to the hemolytic anemia the mitraclip did not cause or contribute to the tdp/hypokalemia, however the cause of hypokalemia is unknown.No additional information provided.

Manufacturer Narrative

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 did not indicate a lot-specific quality issue.It should be noted that the reported patient effects of tissue damage, cerebrovascular accident, hemolysis and tachycardia, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.This event was further reviewed by an abbott vascular medical affairs director who stated in this case of grade 4 degenerative mitral regurgitation (mr), the first clip was implanted in a3/p3 but detached from the anterior leaflet and anterior leaflet injury occurred.A second clip was implanted medial to the first clip, stabilizing the slda clip.Mr was reduced to 3+.Post clip implantation, the patient experienced several complications (embolic disease, hemolytic anemia, hypokalemia resulting in torsades de pointes).3 days post-procedure, mitral valve replacement surgery was performed.The patient recovered and was discharged.In the physician¿s opinion, the mitraclip did not cause or contribute to the embolic disease.The investigation was unable to determine a conclusive cause for the reported single leaflet device attachment/slda and patient effects of cerebrovascular accident, hemolysis and tachycardia.The tissue damage appears to be related to the slda.There is no evidence that the embolic disease was related to the device but maybe related to the procedure.There is no indication of a product issue with respect to manufacture, design, or labeling.Na.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10165901
• MDR Text Key: 195551187
• Report Number: 2024168-2020-05131
• 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: 08/25/2020

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: 10/06/2020
• Device Catalogue Number: CDS0502
• Device Lot Number: 91007U126
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/25/2020
• Initial Date FDA Received: 06/17/2020
• Supplement Dates Manufacturer Received: 08/06/2020
• Supplement Dates FDA Received: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 90 YR
• Patient Weight: 45