MAUDE Adverse Event Report: ETHICON INC. TEFLON PLEDGETS UNKNOWN PRODUCT; PATCH, PLEDGET AND INTRACARDIAC

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

Patient Problem Wound Dehiscence (1154)

Event Date 05/08/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? 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.(b)(4).The single complaint was reported with multiple events.There are no additional details regarding the additional events.Related events captured via 2210968-2021-08545.Citation: citation: citation: catheter cardiovasc interv.(2021); 97(1): e130¿e134.Doi: 10.1002/ccd.28955.

Event Description

Title: first-in-human transcatheter pledget-assisted suture tricuspid annuloplasty for severe tricuspid insufficiency.The aim of this study is to report the first pledget-assisted suture tricuspid annuloplasty (pasta) in a patient with torrential tricuspid regurgitation (tr).An (b)(6) year-old male patient who had an end-stage tr caused by a defibrillator lead consented to undergo pasta on a compassionate basis.Surgery was performed using a pledgeted (teflon pledget; ethicon) size 0 braided polyester suture (ethibond; ethicon).Reported complications included septal annular dehiscence.He underwent closure of the dehisced annulus using gore cardioform devices, with partial seal of the dehiscence.The patient was discharged home and was alive at 6-month follow-up but with persistent symptoms.In conclusion, this case demonstrates that torrential tr can be eliminated by changing the geometry of the tricuspid annulus to form a double-orifice valve and that sutures and pledgets can be delivered percutaneously using off-the-shelf devices.However, the results with a single spanning suture and pledget system in a massively dilated annulus were not durable.Dedicated devices may facilitate multiple spanning sutures via a transjugular approach.

• Brand Name: TEFLON PLEDGETS UNKNOWN PRODUCT
• Type of Device: PATCH, PLEDGET AND INTRACARDIAC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12482965
• MDR Text Key: 273614771
• Report Number: 2210968-2021-08546
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K811872
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• 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: 08/20/2021
• 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
• Patient Age: 83 YR