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

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint: (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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.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 surgeon believe that ethicon products (prolene sutures ¿ standard and hemoseal) involved caused and/or contributed to the post-operative complications (bleeding and transfusions) described in the article? does the surgeon believe there was any deficiency with the ethicon products (prolene sutures) used in this procedure? if yes, please provide patient demographics for the patients that experienced the post-operative complications (bleeding and transfusions).-were these cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Citation: jheor 2017;5(2):140-9.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Title: real-world bleeding outcomes and costs following vascular graft anastomosis using prolene sutures with hemoseal technology in patients undergoing abdominal aortic aneurysm repair.This retrospective study aims to compare real-world bleeding-related outcomes and costs following vascular anastomosis using prolene sutures with hemo-seal technology (hemo-seal sutures) (ethicon) compared with standard prolene sutures (ethicon) in patients receiving abdominal aortic aneurysm (aaa) repair in the united states.From 2009 to 2013, data including 5025 discharges for aaa or possible aaa with hemostat use and use of prolene with hemo-seal sutures (ethicon) (n=79,1.6%, female n=21, male n=58; age range: under 45=2, 45 to 54=4, 55 to 64=10, 65 to 74=33 and over 74=30) or standard prolene sutures (ethicon) (n=4946, 97.3%, female n=1284, male n=3662; age range: under 45=179, 45 to 54=266, 55 to 64=867, 65 to 74= 1759 and over 74=1875) were gathered from a database and was included in the analysis.The majority of discharges (41.8%) were for patients aged between 65 and 74 years in the hemo-seal suture group with a larger number of patients aged over 74 years in the standard prolene suture group (37.9%).The terms ¿hemo-seal¿, ¿hs¿, ¿hemoseal¿, ¿prolene¿, as well as the product identification codes for ethicon hemo-seal suture products were used to identify potential hemo-seal suture and unique hospital charge codes were identified as being standard prolene sutures (eg, non-hemoseal sutures).Bleeding complications (prolene with hemo-seal n=77 and standard prolene n=4893) and transfusions (prolene with hemo-seal n=21 and standard prolene n=2184) were reported.The results indicate that real-world use of hemo-seal sutures may be associated with reduced hemostat usage and costs, and reduced bleeding that requires additional hemostats and/or transfusions.

• Brand Name: PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10940900
• Report Number: 2210968-2020-09527
• Device Sequence Number: 10993636
• Product Code: GAW
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,literatur
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/12/2020

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 12/03/2020
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention