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

Catalog Number CDS0602-NTR

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

Patient Problems Stroke/CVA (1770); Visual Disturbances (2140)

Event Date 09/13/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The clip remains in patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is conservatively filed to report the stroke.It was reported that on (b)(6) 2019, two clips were successfully implanted to treat mixed mitral regurgitation (mr), reducing mr from 3 to 1.On (b)(6) 2019, the patient suffered a stroke, with symptoms of double vision and transient weakness.It is the physicians opinion that the mitraclip devices and procedure did not cause or contribute to the stroke.The patient remains stable and will be receiving rehabilitation services.There was no additional information 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 this event.The reported patient effect of stroke is listed in the mitraclip system instructions for use, as a known possible complication associated with mitraclip procedures.Based on the information reviewed, a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.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: 9158308
• MDR Text Key: 161712734
• Report Number: 2024168-2019-12373
• 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: 10/23/2019

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: 02/15/2020
• Device Catalogue Number: CDS0602-NTR
• Device Lot Number: 90215U115
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/13/2019
• Initial Date FDA Received: 10/04/2019
• Supplement Dates Manufacturer Received: 10/07/2019
• Supplement Dates FDA Received: 10/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OTHER IMPLANTED CLIP
• Patient Outcome(s): Hospitalization; Disability