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 Abscess (1690); Fistula (1862); Hemorrhage/Bleeding (1888); Ischemia (1942); Thrombosis/Thrombus (4440)

Event Date 02/01/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional information has been requested however not received.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: pds ii suture, blake drain, involved caused and/or contributed to the post-operative complications described in the article? pds-ii suture: intraoperative bleeding, portal thrombosis or perforation of the colon caused by ischemia, postoperative pancreatic fistula, intraabdominal abscess, clavien-dindo i complication, clavien-dindo ii complication, clavien-dindo iiia complication, clavien-dindo iiib complication, readmission.Blake drain: postoperative pancreatic fistula, intraabdominal abscess, clavien-dindo i complication, clavien-dindo ii complication, clavien-dindo iiia complication, clavien-dindo iiib complication, clavien-dindo iva complication, readmission.Treatment: the postoperative pancreatic fistula required patients to received octreotide analog therapeutically.The intraoperative bleeding required red blood cell transfusion in patients.The portal thrombosis or perforation of the colon caused by ischemia required reoperation in patient.Does the surgeon believe there was any deficiency with any of the ethicon products: pds ii suture, blake drain, used in these procedures? 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? what surgical or medical intervention has been performed? 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.Note: events reported on mw# 2210968-2021-11137.Citation: annals of surgery (2019);269(2):243-251.Doi: 10.1097/sla.0000000000002802.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Title: modified blumgart mattress suture versus conventional interrupted suture in pancreaticojejunostomy during pancreaticoduodenectomy: randomized controlled trial the aim of this randomized controlled trial (rct) was to evaluate whether mattress suture of pancreatic parenchyma and the seromuscular layer of jejunum (modified blumgart method) during pancreaticojejunostomy (pj) decreases the incidence of clinically relevant postoperative pancreatic fistula (popf) after pancreaticoduodenectomy (pd).Between june 2013 and may 2017, a total of 210 patients with malignant or benign disease of the pancreatic head and periampullary region, who underwent pancreaticoduodenectomy, were randomized to either interrupted suture (n=103 patients; 62 were male; median age of 70 (40¿86) years) or modified blumgart mattress suture (n=107; 59 were male; median age of 68 (24¿90) years).Surgery was performed using a competitor suture in both groups and blake silicone drain 10mm flat, 3/4 fluted (ethicon, inc., (b)(4)) was placed near the pancreatic anastomosis.In the interrupted suture group, anastomosis was performed in a duct-to-mucosa fashion using a single layer of interrupted 5¿0 pds-ii (double-armed, polydioxanone suture; (b)(6) with 8 or more sutures.Reported complications include intraoperative bleeding (n=?) requiring red blood cell transfusion in 5 patients, postoperative pancreatic fistula (n=?) which required 5 patients to received octreotide analog therapeutically, clavien-dindo i complication (n=?), clavien-dindo ii complication (n=?), clavien-dindo iiia complication (n=?), clavien-dindo iiib complication (n=?), clavien-dindo iva complication (n=1), intraabdominal abscess (n=?), portal thrombosis or perforation of the colon caused by ischemia (n=?) requiring reoperation in 1 patient, and readmission (n=?).In conclusion, the mattress suture of pancreatic parenchyma and the jejunal seromuscular layer during pj (modified blumgart technique) did not reduce clinically relevant popf compared with interrupted suture.

Manufacturer Narrative

Product complaint # (b)(4).Additional information has been requested and obtained.If further details are received at a later date a supplemental medwatch will be sent.No further information will be provided because we can¿t get any additional information from the author.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• 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: 12781208
• MDR Text Key: 285471602
• Report Number: 2210968-2021-11138
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/18/2021
• 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