MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMULET DELIVERY SHEATH 14F 80CM

Model Number DS-TV45X45-14F-080

Device Problem Obstruction of Flow (2423)

Patient Problem Thrombus (2101)

Event Date 10/11/2018

Event Type  Injury  

Manufacturer Narrative

An event of thrombus at the tip of the sheath was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Information from the field indicated that the reported thrombus was related to underlying heparin induced thrombocytopenia.

Event Description

On (b)(6) 2018, a 28mm amplatzer amulet (acp2) was selected for implant using a 14f amplatzer torqvue 45x45 delivery sheath.During the procedure, a thrombus was noted at the tip of the delivery sheath due to underlying heparin induced thrombocytopenia (hit) disease which was first treated with at dose of orgaran that was insufficient.The thrombus was successfully treated with aspiration through the delivery sheath.The device was successfully implanted and was monitored for several hours following the procedure and no neurological problems were reported.The patient is reported to be discharged (clinical study patient (b)(6)).

• Brand Name: AMULET DELIVERY SHEATH 14F 80CM
• Type of Device: AMULET DELIVERY SHEATH 14F 80CM
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8045614
• MDR Text Key: 126361142
• Report Number: 2135147-2018-00200
• 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: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: DS-TV45X45-14F-080
• Device Catalogue Number: DS-TV45X45-14F-080
• Device Lot Number: 6378383
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2018
• 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: 83 YR
• Patient Weight: 87