MAUDE Adverse Event Report: ABBOTT VASCULAR MITRA CLIP; MITRAL VALVE REPAIR DEVICES

Model Number CDS0701-XTW

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Date 08/11/2022

Event Type  Injury  

Event Description

Dr.(b)(6) at (b)(6) hospital placed a mitra clip by abbott in our son, (b)(6), dob (b)(6) 1989; on (b)(6) 2022 in his mitral valve.He said (b)(6) had healthy tissue and it grabbed on right away giving him the 85-90% closure he wanted and a screw came loose.In order to keep it from floating to an area causing morbidity he places a 2nd one to pin the 1st one in place.In doing so, he was only able to get 50% closure.Part no.Cds0701- xtw, udi (b)(4).We understand this puts him at a greater risk down the road for chf without proper closure.Our main concern at this time is this device is safe to be in our son and is he at risk of it traveling or causing further risks or complications down the road.We are looking for extra data and studies to support any claim that we will not have medical issues.We feel abbott needs to address this.He had down syndrome and we are his guardians.Fda safety report id# (b)(4).

• Brand Name: MITRA CLIP
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT VASCULAR
• MDR Report Key: 15419653
• MDR Text Key: 300060127
• Report Number: MW5112037
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231001
• UDI-Public: 08717648231001
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 09/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CDS0701-XTW
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 20322R242
• Patient Sequence Number: 1
• Treatment: ASA 81MG DAILY; GINGKO BILOBA 120MG IN AM AND 60MG IN PM; LOSARTAN 25MG DAILY; MULTI-VITAMIN; PRILOSEC 20MG DAILY; PROBIOTIC ; STOOL SOFTENER; VITAMIN D 400 IU
• Patient Outcome(s): Other; Life Threatening; Hospitalization
• Patient Age: 32 YR
• Patient Sex: Male
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White