MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*RL TITAN HEAVY WIRE; STAPLE, IMPLANTABLE

Model Number	TLH30
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Fistula (1862)
Date of Event	07/27/2021
Type of Reportable Event	Serious Injury
Additional 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/batch number has not been provided.Did author do a sub analysis on patient who had complications and compare it to patient who did not? does the surgeon believe there is an alleged deficiency with the device that caused or contributed to patient complication? response: no further information will be provided because we can¿t get any additional information from the author.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be field as appropriate.
Event or Problem Description
It was reported via journal article: title: safe pneumonectomy for locally advanced lung cancer after induction therapy.Author(s): tetsuhiko go, toshihiro ikeda, naoya yokota, atsushi fujiwara, yasuhiro otsuki, ayumu kato, sung soo chang, noriyuki misaki, dage liu, hiroyasu yokomise.Citation: surgery today (2022) 52:316¿323; https://doi.Org/10.1007/s00595-021-02333-2.The purpose of the study is to assess the safety and long-term outcomes of pneumonectomy after induction therapy versus upfront pneumonectomy without induction therapy for locally advanced non-small-cell lung cancer.Between 2000 and 2019, 69 patients with locally advanced non-small-cell lung cancer who underwent pneumonectomy were included in the study.There were 56 males and 13 females with a median age of 65 years (range, 44-78 years).30 patients underwent pneumonectomy without induction therapy (u-pn group) while 29 patients underwent pneumonectomy after induction therapy (it-pn group).The patients underwent pneumonectomy and systematic lymph node dissection.Most pulmonary vessels were stapled and closed.In most cases, proximate tlh 30 (ethicon endo-surgery) or echelon flex (ethicon endo-surgery) were used to close the main bronchus.In the patients who underwent pneumonectomy after induction therapy, all bronchial stumps were reinforced with autologous viable tissue.The chest drainage tube was removed after confirming that there was no bleeding, usually on postoperative day.The reported complications included interstitial pneumonia (n=3), bronchopleural fistula (n=8), acute respiratory distress syndrome (n=7), bleeding (n=2), empyema (n=3), pneumonia (n=4), pulmonary embolism (n=2), recurrent laryngeal nerve paresis (n=5), chronic respiratory failure (n=4), atelectasis (n=1), death within 30¿90 days postoperatively after surgery due to pneumonia from bronchopleural fistula (n=4).In conclusion, pneumonectomy for non-small-cell lung cancer can be performed safely after induction therapy with favorable results.For patients with n2 disease, induction therapy followed by surgery may warrant further study.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 16862372
• Report Number: 3005075853-2023-03026
• Device Sequence Number: 5421119
• Product Code: GDW
• UDI-Device Identifier: 10705036013228
• UDI-Public: 10705036013228
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K020779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/03/2023

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 Model Number: TLH30
• Device Catalogue Number: TLH30
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2023
• Initial Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown