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

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

Patient Problems Cardiac Arrest (1762); Death (1802); High Blood Pressure/ Hypertension (1908); Pleural Effusion (2010); Organ Dehiscence (2502); Blood Loss (2597); No Code Available (3191)

Event Date 12/07/2015

Event Type  Death  

Manufacturer Narrative

(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.

Event Description

It was reported that a patient underwent a cabg procedure on (b)(6) 2015 and suture was used.Post operatively, the patient's blood pressure reached 200mm/hg in the surgical intensive care.The chest was cracked and bilateral pleural effusions were drained and the patient was put on a balloon pump.The patient was critically ill.The proximal anastomosis of the aorta was undone, and the quality of the tissue was terrible around the entire aorta.The patient expired on (b)(6) 2015.Additional information was requested.

Manufacturer Narrative

Date sent to the fda: 04/28/2016, (b)(4).It was reported that, during the procedure, tissue was relatively healthy without calcifications.Three-four days post-op, the patient was suctioned aggressively and the blood pressure spiked >200 and the cardiac arrest occurred.When chest was re-opened, it was noted massive bleeding in the ascending aorta and the suture was ¿unravelled¿.It was indicated that no autopsy was performed.

• Brand Name: PROLENE POLYPROPYLENE SUTURE
• Type of Device: SUTURE, NONABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): UNKNOWN; unknown; x
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 5323180
• MDR Text Key: 34239099
• Report Number: 2210968-2015-21150
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2016
• Was Device Evaluated by Manufacturer?: No
• 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: 70 YR