MAUDE Adverse Event Report: ETHICON INC. PRONOVA BLUE SUTURE UNKNOWN PRODUCT; SUTURE, NON ABSORBABLE

Device Problem Insufficient Information (3190)

Patient Problems Hematoma (1884); Blood Loss (2597); 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.No specific patient information regarding events has been provided.Citation: the journal of thoracic and cardiovascular surgery.2006; 131(1).Doi: 10.1016/j.Jtcvs.2005.07.064.(b)(4).

Event Description

It was reported via journal article title: technical challenges in totally endoscopic robotic coronary artery bypass grafting.Authors: j.Bonatti, md, fetcs; t.Schachner, md; n.Bonaros, md; a.Öhlinger, md; m.Danzmayr; p.Jonetzko, md; g.Friedrich, md; c.Kolbitsch, md, deaa; p.Mair, md; g.Laufer, md citation: the journal of thoracic and cardiovascular surgery.2006; 131(1).Doi: 10.1016/j.Jtcvs.2005.07.064.The aim of the study was to describe surgeon-related technical difficulties in arrested heart totally endoscopic coronary artery bypass (ahtecab) during an implementation phase, to evaluate risk factors and to determine the clinical consequences associated with undesirable surgical events.A total of 40 patients underwent ahtecab between october 2001 and october 2004.The overall coronary artery bypass grafting number during the time frame of the study was 1073, and totally endoscopic coronary artery bypass (tecab) was performed in 40 (4%) patients.During the procedure, the target vessel was exposed and incised with a lancet endoscopic knife.The left internal thoracic artery (lita) was then sutured robotically to the target vessel with a pronova 7-0 running suture.The sternal and heel parts of the anastomosis were sutured first and carried out in an outside-in manner, and thereafter, the toe of the anastomosis and the lateral portion were carried out in an inside-out manner.Reported complications included lita bleeding (n-1; 3%) and lita intramural hematoma (n-3; 8%) which required conversion and revision surgery, anastomotic stenosis (n-2; 5%) which was repaired immediately, anastomotic bleeding (n-4; 10%) which required revision procedure (n-2), and target vessel occlusion close to the heel of the anastomosis (n-2).It was reported that one possible explanation for the target vessel occlusion could be the current suture technique, in which the heel stitches are placed on the target vessel in an outside-in fashion.Local plaque mobilization might have been a consequence of this technique, leading to local vessel obstruction by the plaque.It was concluded that during the implementation phase of telemanipulation-enhanced tecab carried out on the arrested heart with remote access perfusion, technical challenges might be frequently encountered.With proper monitoring of these events, rigorous intraoperative quality control, close postoperative observation, and immediate surgical reaction, however, the sequelae for the patients are acceptable.

• Brand Name: PRONOVA BLUE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NON ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7490945
• MDR Text Key: 107562171
• Report Number: 2210968-2018-72630
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K001625
• 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: 04/13/2018

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2018
• Initial Date FDA Received: 05/07/2018
• 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): Required Intervention