MAUDE Adverse Event Report: ST. JUDE MEDICAL AMULET DELIVERY SHEATH 12F 80CM

Model Number DS-TV45X45-12F-080

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

Patient Problem Thrombosis (2100)

Event Date 07/13/2020

Event Type  Injury  

Manufacturer Narrative

An event of deep vein thrombosis was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

On (b)(6) 2020, a 22m amplatzer amulet was successfully implanted.On (b)(6) the patient present to the hospital due to suspected deep vein thrombosis 11 days post implant procedure.A deep vain thrombosis was confirmed by ultrasound and ct scan.The patient was admitted and received therapeutically anticoagulation and elastic stocking.The patient was reported to be in stable condition and will be monitored.(crd_859 - laao-pas, eu2111-979; r548742501).

• Brand Name: AMULET DELIVERY SHEATH 12F 80CM
• Type of Device: AMULET DELIVERY SHEATH 12F 80CM
• Manufacturer (Section D): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345 2126
• Manufacturer (Section G): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345 2126
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 10527698
• MDR Text Key: 206764382
• Report Number: 2182269-2020-00084
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: DS-TV45X45-12F-080
• Device Lot Number: 7380666
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 98