MAUDE Adverse Event Report: ETHICON INC. PDS*II VLT 0 45CM - ENDOLOOP; LAPROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number EZ10G03

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

Patient Problems Bradycardia (1751); Inflammation (1932); Thromboembolism (2654); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is related to a journal article, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.The following information was requested but unavailable: were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that ethicon products (endo loop suture) involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products (endo loop suture) used in this procedure? citation: heart rhythm.2018; 15:1314¿1320.Doi: https://doi.Org/10.1016/j.Hrthm.2018.05.026.(b)(4).

Event Description

It was reported via journal article: "title: thoracoscopic stapler-and-loop technique for left atrial appendage closure in nonvalvular atrial fibrillation: mid-term outcomes in 201 patients" authors: toshiya ohtsuka, md; takahiro nonaka, md; motoyuki hisagi, md; mikio ninomiya, md; ai masukawa, md; takahiro ota, md citation: heart rhythm.2018; 15:1314¿1320.Doi: https://doi.Org/10.1016/j.Hrthm.2018.05.026.Left atrial appendage (laa) closure can be an alternative to oral anticoagulation to prevent cardiogenic thromboembolisms in patients with nonvalvular atrial fibrillation.The purpose of this study was to retrospectively evaluate the safety, completeness, and mid-term prevention of our thoracoscopic stapler-and-loop technique for laa closure.A total of 201 patients (118 male and 83 female patients; age range: 68 to 94 years old) operated on between october 2008 and february 2017 were reviewed.During the surgical procedure, the authors used an automatic, bendable cut-and-staple echelon flex powered endopath 60 stapler device (ethicon), which can cut and close 6-cm-long tissue with a single cartridge.If any small protrusion was observed at either end of the staple line, an endoloop ligature ez10g endoscopic ligation tool (ethicon) was used to obliterate it.Intraoperative tee was used for quality control.Reported complications included clot formation exclusively at the apical portion of laa (n-11), cardiogenic thromboembolism (n-4) in which 2 were treated with warfarin to maintain relatively high international normalized ratio, air leakage (n-6), bradycardia (n-1) which required readmission and treatment with pacemaker implantation, pericarditis (n-1) which required readmission and treatment with steroid administration, post-pericardiotomy syndrome (n-28) which were treated with non-steroidal anti-inflammatory medication, stump (n-3), narrow protrusion at the caudal end of the staple line (n-4), and left atrial clot along the cut-line (n-2) which required anti-coagulant therapy for another 2 months.The thoracoscopic stapler-and-loop technique swiftly closed the laa with satisfactory safety and completeness.The 4-year mid-term preventive efficacy was acceptable, and the brain mri study provided supporting evidence.The minimally invasive off-pump technique seems promising as an effective alternative when long-term oral anticoagulation is difficult in patients with nvaf, particularly in those with an laa featuring a relatively large size or complex morphology.

• Type of Device: LAPROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-BRAZIL; rodovia presidente dutra; km 154; sao paolo 12240 -908; BR 12240-908
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8692176
• MDR Text Key: 147759687
• Report Number: 2210968-2019-82667
• Device Sequence Number: 1
• Product Code: GEA
• UDI-Device Identifier: 10705031206427
• UDI-Public: 10705031206427
• Combination Product (y/n): N
• PMA/PMN Number: K925914
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EZ10G03
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention