MAUDE Adverse Event Report: ST. JUDE MEDICAL CATD SJM REGENT HEART VALVE W/FLEX CUFF; HEART-VALVE, MECHANICAL

Model Number 19AGFN-756

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/07/2019

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2019, a 19mm regent mechanical heart valve was selected for implant as part of an aortic valve replacement.During device preparation, when the valve was opened for examination, foreign material was found on the valve and it was exchanged for a new 19mm regent mechanical heart valve (serial #: (b)(4)).It was reported that there was extended operation time due to the exchange.

Event Description

On (b)(6) 2019, a 19mm regent mechanical heart valve was selected for implant as part of an aortic valve replacement.When the valve was opened for examination, foreign material was found on the valve and it was exchanged for an unknown sized unknown valve.It was reported that there was extended operation time due to the exchange.

Manufacturer Narrative

The reported event of foreign material on the valve was reported.A photo from the field appeared to show a foreign material present on the collar of the valve.The valve and valve holder were received at abbott, and no foreign material was found on either component.The collar was not received at abbott.The origin of the foreign material seen in the photo could not be conclusively determined, as the valve jar had been opened in the field.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization, which includes inspection for foreign material prior to sterilization and again prior to final packaging.The cause of the reported event could not be conclusively determined.

• Brand Name: SJM REGENT HEART VALVE W/FLEX CUFF
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL CATD; 4 robbins drive; westford MA 01886
• MDR Report Key: 9233411
• MDR Text Key: 163617133
• Report Number: 2648612-2019-00085
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734005852
• UDI-Public: 05414734005852
• Combination Product (y/n): N
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 19AGFN-756
• Device Catalogue Number: 19AGFN-756
• Device Lot Number: 7027568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention