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

Catalog Number CDS0502

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

Patient Problems Aneurysm (1708); Death (1802); Hemorrhage/Bleeding (1888); Nausea (1970)

Event Date 07/31/2020

Event Type  Death  

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.Na.

Event Description

This is being conservatively filed to report that one month post procedure, the patient died.It was reported that the index mitraclip procedure was performed on (b)(6) 2020 to treat functional mitral regurgitation (mr) with grade 4.One clip was implanted, reducing mr to 1-2.On (b)(6) 2020, the patient was re-hospitalized and was told that there was no gastrointestinal bleeding.There was no evidence of rupture of the heart or vascular system.However, the patient at the time of death vomited blood and died.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The investigation determined the reported death, nausea and hemorrhage appear to be related to the rupture of an aortic aneurysm; however, a cause for the aneurysm cannot be determined.In addition, death, nausea, hemorrhage and aneurysm are listed in the mitraclip instructions for use as a known possible complication associated with mitraclip procedures.The reported hospitalization was a result of case specific circumstance.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

Event Description

Subsequent to the initial report filing, additional information received reported that on (b)(6)2020 , the patient visited the hospital for mitraclip follow-up on which confirmed that both valve leaflets were firmly grasped and stable and there was no tissue damage.The hemorrhage was observed in the right thoracic cavity just before death, and the cause of death was not not gastrointestinal bleeding but rupture of an aortic aneurysm.No additional information was provided.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10593716
• MDR Text Key: 208784276
• Report Number: 2024168-2020-08049
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/29/2020

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: 04/06/2021
• Device Catalogue Number: CDS0502
• Device Lot Number: 00403U187
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/04/2020
• Initial Date FDA Received: 09/28/2020
• Supplement Dates Manufacturer Received: 10/07/2020
• Supplement Dates FDA Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 63 YR
• Patient Weight: 60