MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT; SUTURE, NONABSORBABLE

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Hemoptysis (1887); Shock (2072)

Event Type  Death  

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.Attempts are being made to obtain the following information.If further details are received at the later date a supplemental medwatch will be sent.Does the surgeon believe that the ethicon product involved caused and/or contributed to the postoperative complications described in the article? does the surgeon believe that prolene suture caused/ contributed to the patient death? does the surgeon believe there was any deficiency with the ethicon suture product prolene used in this procedure? would the surgeon like to speak with ethicon medical and engineering? citation: thorac cardiovasc surg 2018;66:187¿192.

Event Description

It was reported via journal article title: outcomes of patients with behçet¿s syndrome after pulmonary endarterectomy author(s): sehnaz olgun yildizeli, mehmed yanartas, serpil tas, haner direskeneli, bülent mutlu, berrin ceyhan, bedrettin yildizeli citation: thorac cardiovasc surg 2018;66:187¿192; doi: https://doi.Org/10.1055/s-0037-1604411.This study aimed to review the authors¿ experience in the surgical treatment of chronic thromboembolic pulmonary hypertension in patient with behçet¿s syndrome (bs).Between mar2011 and mar2017, 9 patients with bs was identified and underwent pulmonary endarterectomy.A (b)(6) -year old female patient with huge thrombosed aneurysm of right lower lobe underwent pulmonary endarterectomy for which the hole in the pulmonary artery of lower lobe was closed with a 6/0 prolene suture and was weaned from cardiopulmonary bypass without any problem.Four weeks later from discharge, the patient was readmitted due to sudden onset of hemoptysis and near shock.A venoarterial extracorporealmembrane oxygenation (ecmo) was instituted and right lower lobectomy was performed.However, the patient not able to be weaned from ecmo and was dead on the 31st postoperative day (pod) of pea.Pulmonary endarterectomy is a complex procedure that can be safely performed only in expert centers based on a high level of experience of an interdisciplinary team.

• Brand Name: PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NONABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7631171
• MDR Text Key: 112144842
• Report Number: 2210968-2018-73699
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K133356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/11/2018
• Initial Date FDA Received: 06/22/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 21 YR