MAUDE Adverse Event Report: ETHICON INC. PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT; SUTURE, SURGICAL, ABSORBABLE

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

Patient Problem Pneumothorax (2012)

Event Date 12/26/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Device not returned.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.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.Does the author/surgeon believe that ethicon products (pds ii suture) involved caused and/or contributed to post-op complications (postoperative prolonged air leakage) described in the article? please specify.Does the author/surgeon believe there was any deficiency with the ethicon products (pds ii suture) used in this study? if yes, please describe.If yes, please provide patient demographics for patients that experienced the post-operative complications (postoperative prolonged air leakage)? were all these cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Citation: journal of thoracic disease (2020);12(3):484-492.Doi: 10.21037/jtd.2020.01.01.

Event Description

Title: feasibility of autologous fibrin glue in general thoracic surgery the purpose of this retrospective study was to investigate the feasibility of afgs in thoracic surgery.A total of 207 patients with lung pathologies underwent lung surgery, including 118 lobectomies and 89 segmentectomies between november 2016 and september 2017.Among them, 83 patients (42 male and 41 female; mean age (b)(6) received partially-autologous fibrin glue (pafg), 94 patients (56 male and 38 female; mean age (b)(6) received completely-autologous fibrin glue (cafg), and 30 patients (18 male and 12 female; mean age (b)(6)) received non-afg.After anatomical lung resection plus nodal dissection, major air leakage points were repaired using 4-0 pds suture (ethicon, inc., cincinnati, oh, usa).Reported complication includes postoperative prolonged air leakage (n=28) requiring reinsertion of a chest tube in 3 patients or chemical pleurodesis for patients who had air leakage of less than 7 days.In conclusion, both types of afg are clinically feasible and showed satisfactory outcomes for patients who undergo lobectomies or segmentectomies.Afg could be a viable alternative to conventional allogenic fibrin glues.Further studies are desired to validate their effectiveness.

Event Description

Title: feasibility of autologous fibrin glue in general thoracic surgery the purpose of this retrospective study was to investigate the feasibility of afgs in thoracic surgery.A total of 207 patients with lung pathologies underwent lung surgery, including 118 lobectomies and 89 segmentectomies between november 2016 and september 2017.Among them, 83 patients (42 male and 41 female; mean age 67.4±11.5 received partially-autologous fibrin glue (pafg), 94 patients (56 male and 38 female; mean age 66.6±12.2 received completely-autologous fibrin glue (cafg), and 30 patients (18 male and 12 female; mean age 71.0±11.1 received non-afg.After anatomical lung resection plus nodal dissection, major air leakage points were repaired using 4-0 pds suture (ethicon, inc., cincinnati, oh, usa).Reported complication includes postoperative prolonged air leakage (n=28) requiring reinsertion of a chest tube in 3 patients or chemical pleurodesis for patients who had air leakage of less than 7 days.In conclusion, both types of afg are clinically feasible and showed satisfactory outcomes for patients who undergo lobectomies or segmentectomies.Afg could be a viable alternative to conventional allogenic fibrin glues.Further studies are desired to validate their effectiveness.

Manufacturer Narrative

Product complaint # (b)(4).Device not returned.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.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.Does the author/surgeon believe that ethicon products (pds ii suture) involved caused and/or contributed to post-op complications (postoperative prolonged air leakage) described in the article? please specify.Does the author/surgeon believe there was any deficiency with the ethicon products (pds ii suture) used in this study? if yes, please describe.If yes, please provide patient demographics for patients that experienced the post-operative complications (postoperative prolonged air leakage)? were all these cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Citation: journal of thoracic disease (2020);12(3):484-492.Doi: 10.21037/jtd.2020.01.01.

• Brand Name: PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12708346
• MDR Text Key: 285152294
• Report Number: 2210968-2021-10449
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention