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 Problems Hemorrhage/Bleeding (1888); Unspecified Vascular Problem (4441); Renal Impairment (4499)

Event Date 01/01/2016

Event Type  Death  

Event Description

This is filed to report patient death.The study compared outcomes of transcatheter mitral valve repair using mitraclip in patients vs surgical mitral valve repair (mvr).30 patients met the inclusion criteria.Complications included death, acute kidney injury, bleeding, and vascular complications.The article concluded that mitraclip may thus present itself as a safer alternative in patients with advanced age where frailty and multiple co-morbidities render them at high risk for open-heart surgery.Specific patient information is documented as unknown.Details are listed in the attached article, titled outcomes of mitraclip and surgical mitral valve repair in patients with left ventricular assist device.No additional information was provided.

Manufacturer Narrative

The clip remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional patient effects and reported in the article are captured under separate medwatch report.Event and implant date: dates estimated.The udi number is not known as the part and lot number were not provided.

Event Description

N/a.

Manufacturer Narrative

The devices were not returned for analysis and a review of the lot history record and similar complaint review could not be performed as the part and lot information regarding the complaint device was not provided.The investigation was unable to determine a cause for the reported deaths.Death is listed in the 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.

• 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: 14434936
• MDR Text Key: 292016906
• Report Number: 2024168-2022-05346
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/07/2022

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: 04/25/2022
• Initial Date FDA Received: 05/19/2022
• Supplement Dates Manufacturer Received: 06/13/2022
• Supplement Dates FDA Received: 07/07/2022
• 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): Death
• Patient Age: 61 YR
• Patient Sex: Male