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

Catalog Number CDS0602-XTR

Device Problem Insufficient Information (3190)

Patient Problem Heart Failure (2206)

Event Date 06/25/2019

Event Type  Death  

Manufacturer Narrative

Exemption number (b)(4).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar incidents reported from this lot.The reported patient effects of heart failure and death as listed in the mitraclip system instructions for use are a known possible complications associated with mitraclip procedures.This event was further reviewed by an abbott vascular medial affairs director, who stated that: given the successful procedure and the time between the procedure and the event, device issue is unlikely, and the most probable cause of death was disease progression with worsening heart failure.All available information was investigated, and a definitive cause for the reported heart failure could not be determined; however, hospitalization was an outcome of patient experiencing heart failure.It is possible that patient death was an outcome of procedural circumstances and post procedure patient anatomical challenges; however, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Study patient (b)(6).This is filed for patient death.It was reported that the patient underwent a mitraclip procedure on (b)(6) 2019, treating functional mitral regurgitation (mr) of grade 4+.Two mitraclips were implanted and the mr was reduced to grade 1+.On (b)(6) 2019, the patient was re-hospitalized with worsening heart failure and died on (b)(6) 2019.It is unknown if the patient¿s death is related to a device issue.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: 9439512
• MDR Text Key: 169896134
• Report Number: 2024168-2019-14309
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/09/2019

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: 12/20/2019
• Device Catalogue Number: CDS0602-XTR
• Device Lot Number: 81218U174
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2019
• Initial Date FDA Received: 12/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2018
• 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
• Treatment: CDS0602-XTR / 81221U169
• Patient Outcome(s): Death
• Patient Age: 80 YR
• Patient Weight: 60