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 Problems Fistula (1862); Unspecified Infection (1930); Ischemia (1942); 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.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 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 the ethicon products used in this procedure? citation: citation: eur j vasc endovasc surg (2017) 54, 697e705; https://doi.Org/10.1016/j.Ejvs.2017.09.002.[(b)(4) - acosta 2017.Pdf].

Event Description

Journal article title ¿open abdomen therapy with vacuum and mesh mediated fascial traction after aortic repair: an international multicentre study: the aim of this retrospective, multicentre study was to analyze the primary delayed fascial closure (pdfc) rate and complications after open abdomen therapy with vacuum and mesh mediated fascial traction (vacm) after aortic repair and to compare outcomes between those treated with open abdomen after primary versus secondary operation.Among 191 patients, 155 were men.These patients were divided into 2 groups: open abdomen at primary operation (n=103) and open abdomen at secondary operation (n=88).The median age was 71 years (iqr 66-76).All consecutive patients treated with open abdomen with vacm after surgery for aortic disease in the scandinivian sites, between 2006 and 2015 were included in the study.A polypropylene mesh was applied at the first redressing after 2 to 3 days.A 30x30 cm mesh (prolene; ethicon, johnson & johnson, somerville, nj, usa) was divided in two halves and sutured to the fascial edges on each side with a running 0 polypropylene suture (prolene).The two mesh halves were then sutured in the midline with a running 0 polypropylene suture, ventral to the polyethylene sheet.The fascia was then closed with a running 0 polydioxanone suture (pds ii, ethicon), by means of a standardized suturing technique aiming at a suture length to wound length ratio of at least 4:1.There were 9 patients who developed entero-atmospheric fistula.There were 7 graft infections.All seven graft infections were managed conservatively with antibiotics and without graft explantation.There were 36 patients developed intestinal ischemia.Two stent graft infections were also treated by percutaneous insertion of two large caliber drains through the back into the aneurysm sac for drainage and intermittent sac irrigation with saline for weeks.In conclusion, vacuum and mesh mediated fascial traction was associated with a high primary delayed fascial closure rate after long-term open abdomen therapy following aortic surgery in this international multicentre study.¿.

• Brand Name: PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• 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: 7639878
• MDR Text Key: 112431663
• Report Number: 2210968-2018-73859
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• 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: 06/01/2018
• 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