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

Catalog Number	9-TV45X45-12F-080
Medical Device Problem Codes	Use of Device Problem (1670); Positioning Problem (3009)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001); Pericardial Effusion (3271)
Date of Event	12/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 22mm amplatzer amulet left atrial appendage occluder was selected for implant on (b)(6) 2024 using a 12f amplatzer torqvue 45x45 delivery sheath.The patient was in sinus rhythm.There were two previously failed attempts to implant a 27mm non-abbott device and a 24mm non-abbott device.The patient had a complex, shallow left atrial appendage.Transseptal puncture was inferior mid.The patient's left atrial pressure was 6mmhg.The 22mm occluder was unable to be implanted in a stable location and was re-captured 3 times.The occluder was removed from the patient.The decision was made to use a 25mm amplatzer amulet left atrial appendage occluder.During device preparation it was noted that there was a localized and growing circumferential pericardial effusion that was measured approximately 1cm.A pericardiocentesis was performed and 300ml of blood was drained from the pericardium.The patient remained stable and was monitored.Approximately 15 minutes later the patient was bleeding again and the decision was made to convert the patient to surgery.During surgery a moderately-sized perforation was noted to the back wall of the appendage.A non-abbott device was implanted to close the laa and stop the bleeding.The surgeon believed the delivery sheath caused the pericardial effusion during the full recapture of the 22mm occluder.The 25mm did not make contact with the patient.The patient status was stable.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of position problem and use of device problem was reported.A returned device 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.Additionally, a review of the complaint history identified no similar incidents reported from this lot.Based on the information received, the reported use of device problem could not be determined.The reported positioning problem appears to be related to complex anatomy.The patient effects of pericardial effusion appears to be related to procedural conditions.Perforation and bleeding could not be determined.The reported unexpected medical intervention and surgical intervention were a result of case-specific circumstances.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Codes removed: health effect-clinical code.
Event or Problem Description
It was reported that a 22mm amplatzer amulet left atrial appendage occluder was selected for implant on (b)(6) 2024 using a 12f amplatzer torqvue 45x45 delivery sheath.The patient was in sinus rhythm.There were two previously failed attempts to implant a 27mm non-abbott device and a 24mm non-abbott device.The patient had a complex, shallow left atrial appendage.Transseptal puncture was inferior mid.The patient's left atrial pressure was 6mmhg.The 22mm occluder was unable to be implanted in a stable location and was re-captured 3 times.The occluder was removed from the patient.The decision was made to use a 25mm amplatzer amulet left atrial appendage occluder.During device preparation it was noted that there was a localized and growing circumferential pericardial effusion that was measured approximately 1cm.A pericardiocentesis was performed and 300ml of blood was drained from the pericardium.The patient remained stable and was monitored.Approximately 15 minutes later the patient was bleeding again and the decision was made to convert the patient to surgery.During surgery a moderately-sized perforation was noted to the back wall of the appendage.A non-abbott device was implanted to close the laa and stop the bleeding.The surgeon believed the delivery sheath caused the pericardial effusion during the full recapture of the 22mm occluder.The 25mm occluder did not make contact with the patient.The patient status was stable.

• Brand Name: AMPLATZER TORQVUE 45X45 DELIVERY SHEATH
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 21028189
• Report Number: 2135147-2024-06642
• Device Sequence Number: 9180658
• Product Code: DQY
• UDI-Device Identifier: 05415067025883
• UDI-Public: (01)05415067025883(17)260731(10)9178438
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K163000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Catalogue Number: 9-TV45X45-12F-080
• Device Lot Number: 9178438
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2024
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 22MM AMPLATZER AMULET[9-ACP2-007-22, LOT: 9054935]
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown