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

Catalog Number CDS0601-XTR

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

Patient Problems Mitral Valve Stenosis (1965); Atrial Perforation (2511)

Event Date 12/12/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number e2019001.The device was not returned for evaluation.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 effects of mitral stenosis and atrial perforation as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.Based on the information provided, the definitive cause for the reported mitral stenosis could not be confirmed.The reported atrial perforation appears to be due to procedural circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

This is filed for mitral stenosis and atrial septal defect (asd).It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+.One clip was implanted without issue.A second clip was implanted without issue; however, it was noted that the mean pressure gradient (mpg) increased from 2 mmhg to 6 mmhg.Mr was reduced to grade 1+.The patient was in stable condition, with no adverse patient sequela.No additional intervention was performed to treat the increased mpg.The physician chose to place an atrial septal defect (asd) closure device at the end of the procedure, closing the asd puncture site.It was noted that the asd was not larger than expected and was not causing an adverse patient effect.Post procedure, the patient was in stable condition.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
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 9532291
• MDR Text Key: 176558523
• Report Number: 2024168-2019-15075
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648226366
• UDI-Public: 08717648226366
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/30/2019

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: 09/22/2020
• Device Catalogue Number: CDS0601-XTR
• Device Lot Number: 90923U118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2019
• Initial Date FDA Received: 12/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR
• Patient Weight: 64