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

Catalog Number CDS0502

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

Patient Problems Stroke/CVA (1770); Weakness (2145)

Event Date 01/21/2020

Event Type  Injury  

Manufacturer Narrative

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 stroke, prolonged hospitalization, and medical intervention.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.On (b)(6) 2020, one clip was successfully deployed, reducing mr to 2.There were no adverse patient effects and no reported clinically significant delay in the procedure.After the procedure, the patient was experiencing symptoms of cerebral infarction which is an indication of a possible stroke.It was noted that the patient was weak after awakening from general anesthesia.Angiography was performed and testing of the cerebral vessel condition was confirmed, and the physician determined the patient had stenosis.As of (b)(6) 2020, the patient continued to be on anticoagulants and the patient's condition improved.The patient recovered from the stroke.The physician stated that the relationship between the event and the clip is unknown.The clip remains stable on both leaflets, and mr is 2.The patient will remain hospitalized and discharged after rehabilitation.No additional information was 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.The physical weakness is the result of the cerebrovascular accident.Based on the information provided a conclusive cause for the reported cerebrovascular accident cannot be determined.It is possible that the cerebrovascular accident is the result of the mitraclip procedure, however this cannot be conclusively determined.The reported patient effects of physical weakness and cerebrovascular accident as listed in the mitaclip system instructions for use are known possible complications associated with mitraclip procedures.Based on the information reviewed, there is no indication of a product issue with respect to manufacture, design or labeling; therefore, no product-related corrective action will be implemented in this case.

• 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: 9687696
• MDR Text Key: 179435433
• Report Number: 2024168-2020-01320
• 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: 02/18/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/15/2020
• Device Catalogue Number: CDS0502
• Device Lot Number: 90810U185
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/28/2020
• Initial Date FDA Received: 02/10/2020
• Supplement Dates Manufacturer Received: 02/11/2020
• Supplement Dates FDA Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability