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

Catalog Number UNK CDS

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

Patient Problem Hematoma (1884)

Event Date 10/08/2019

Event Type  Injury  

Manufacturer Narrative

Dates estimated.The devices were not returned for analysis.A review of the lot history record could not be performed as this incident was based on transcatheter valve therapy (tvt) registry data, and no device/lot information was provided.Based on available information, a cause for the reported hematoma could not be determined.Furthermore, the reported patient effect of hematoma is listed in the mitraclip instructions for use as a known possible complication associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design, or labeling.

Event Description

It was reported through transcatheter valve therapy (tvt) registry data that mitraclip devices may be related to 17 hematoma events which is considered a serious injury.The relationship of the adverse events to the mitraclip device could not be determined based on the limited data received from the registry.Tvt registry data is reported as a summary per summary reporting exemption approval number - e2015009.No additional information was provided.

Manufacturer Narrative

The devices were not returned for analysis.A review of the lot history record could not be performed as this incident was based on transcatheter valve therapy (tvt) registry data, and no device/lot information was provided.Based on available information, a cause for the reported hematoma could not be determined.Furthermore, the reported patient effect of hematoma is listed in the mitraclip instructions for use as a known possible complication associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design, or labeling.Added exception #2015009.

Manufacturer Narrative

The devices were not returned for analysis.A review of the lot history record could not be performed as this incident was based on transcatheter valve therapy (tvt) registry data, and no device/lot information was provided.Based on available information, a cause for the reported hematoma could not be determined.Furthermore, the reported patient effect of hematoma is listed in the mitraclip instructions for use as a known possible complication associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design, or labeling.H1: summary no.Of events.

• 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: 12026105
• MDR Text Key: 262483897
• Report Number: 2024168-2021-05146
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 17
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/26/2022

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 Catalogue Number: UNK CDS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/14/2021
• Initial Date FDA Received: 06/18/2021
• Supplement Dates Manufacturer Received: 03/14/2022; 05/06/2022
• Supplement Dates FDA Received: 04/07/2022; 05/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 71 YR