MAUDE Adverse Event Report: ETHICON INC. TEFLON PLEDGETS UNKNOWN PRODUCT; PATCH, PLEDGET AND INTRACARDIAC

Device Problems Migration or Expulsion of Device (1395); Appropriate Term/Code Not Available (3191)

Patient Problems Abscess (1690); Adhesion(s) (1695); Erosion (1750); Cyst(s) (1800); Fistula (1862); Inflammation (1932); Pain (1994); Respiratory Distress (2045); Scar Tissue (2060); Not Applicable (3189)

Event Date 11/04/2016

Event Type  Injury  

Manufacturer Narrative

Date sent to the fda: 11/03/2017.(b)(4).To date the device has not been returned.If the device or further details are received at the later date, a supplemental medwatch will be sent.

Event Description

It was reported that the patient underwent a left diaphragm rupture repair, exploratory laparotomy, partial gastric resection to repair gastric perforation, splenectomy and herniation of abdominal contents in to the left thoracic cavity procedure on (b)(6) 2011 and the unknown pledgets were used to reinforce the suture line.Pledgets were done individually and were all tied at the very end; then it was noted that there was a secure and tight closure of the left diaphragmatic injury.During the procedure, copious amounts of gastric contents were noted in the intraabdominal and left thoracic cavity as well as gastric ischemia.After the surgery, the patient experienced ongoing pain.The pain was bad enough and the patient experienced trouble breathing.It was reported by the patient¿s daughter that on (b)(6) 2016 the patient went back to hospital, bent over in pain and felt like something pulling inside with trouble breathing.Imaging revealed a foreign body inside of the patient.It was also reported that the patient was taken back to or on (b)(6) 2017 for intraabdominal catastrophes with stomach and colon erosions by potential retained items.During second surgery, following procedures, such as lysis of severe adhesions, excision of cicatrix, distal pancreatectomy, coagulation hepatorrhaphy, proximal gastrectomy, esophagogastrostomy, anastomosis with distal esophagus and stomach, partial omentectomy, transverse colectomy, and resection of abdominal wall cyst and splenic flexure of colon, were performed.Gastrocutaneous fistula, severe adhesions through all peritoneum, pancreatic and hepatic erosion, inflammation, scar and abscess in the upper quadrant on the left and eroding into the abdominal and chest wall were noted.It was evident that something had eroded into the colon of the splenic flexure, into the liver, into the pancreas and into the stomach.The left lobe of the liver was part of the abscess cavity and retained pledgets were removed as part of this abscess.The greater curve of the stomach had eroded and was open and draining into this abscess cavity and there was a great deal more pledgets within this area and into the wall of the stomach.The pledgets were removed up in this area, but the stomach itself was eroding and had multiple holes in this area.After second surgery, the patient was on life support for four to five months, then one month off of life support before he was moved to a nursing home.The patient passed away the same day he was moved to the nursing home, on (b)(6) 2017.

Manufacturer Narrative

Product complaint #
=
> pc-000040469 corrected information.Additional information:  facility representative indicated this patient was in poor health and malnourished at the time of the reoperation.  the surgeon stated that he did not implicate the ethicon product as causative of the patient¿s complications but rather, while the pledgets were involved in the complications, they were in no way the cause of the complications.The surgeon opined that this is a not unexpected but very rare complication that can sometimes occur with foreign bodies implanted at the time of a contaminated surgical field. .

• Brand Name: TEFLON PLEDGETS UNKNOWN PRODUCT
• Type of Device: PATCH, PLEDGET AND INTRACARDIAC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenidadelastorres; 7125,col salvacar; ciudad juarez ; MX
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 7000387
• MDR Text Key: 91000157
• Report Number: 2210968-2017-70768
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• PMA/PMN Number: K811872
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/09/2017

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: 10/09/2017
• Initial Date FDA Received: 11/03/2017
• Supplement Dates Manufacturer Received: 12/12/2017
• Supplement Dates FDA Received: 12/21/2017
• 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; Required Intervention
• Patient Age: 65 YR