MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER TORQVUE 45X45 DELIVERY SHEATH; CATHETER, PERCUTANEOUS

Model Number	9-TV45X45-14F-100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Pericardial Effusion (3271)
Date of Event	03/08/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
On (b)(6) 2017, a 31mm amplatzer amulet was implanted.On (b)(6) 2017, a tee revealed a small pericardial effusion and was deemed not clinically significant.No intervention was performed.On (b)(6) 2017, the patient was reported to have expired.Of note, the death was not related to the implant device or procedure.(clinical study patient id: (b)(6)).

• Brand Name: AMPLATZER TORQVUE 45X45 DELIVERY SHEATH
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 8696972
• Report Number: 2135147-2019-00167
• Device Sequence Number: 14014929
• Product Code: DQY
• UDI-Device Identifier: 00811806014111
• UDI-Public: 00811806014111
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: 9-TV45X45-14F-100
• Device Catalogue Number: 9-TV45X45-14F-100
• Device Lot Number: 5761507
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/16/2019
• Supplement Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 08/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Other
• Patient Age: 80 YR
• Patient Weight: 80