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

Device Problem Insufficient Information (3190)

Patient Problems Dyspnea (1816); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).(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.If further details are received at the later date a supplemental medwatch will be sent.(b)(4).

Event Description

Title: the left main complication of the bentall¿s procedure.A (b)(6) gentleman presented originally in 2009 for routine health assessment prior to competing in the (b)(6) marathon.Examination revealed a systolic murmur and an echocardiogram indicated moderate to severe aortic stenosis.In (b)(6) 2010, given the combination of moderate to severe aortic stenosis and a dilated ascending aorta, the patient underwent aortic root and ascending aorta replacement with a hemi arch replacement.During the procedure, the left main coronary artery was then re-implanted with prolene 5-0 suture material.Twelve months after surgery, the patient was presented with exertional dyspnea.The patient¿s ct coronary angiogram suggested a very tight ostial stenosis.He then underwent coronary artery bypass grafting with an lima to lad graft.Almost 2 years following the second operation the patient remains well.It was reported that the presumed mechanisms for ostial left main stenosis following the bentall¿s procedure included an inflammatory fibrous reaction to the suture material or tissue glue used during re-implantation of the coronary arteries, suture methods that result in kinking or stretching of the vessel, or a result of instrumentation of the coronary ostia during the induction of cardioplegia.It was concluded that the bentall¿s procedure is a well proven operation with excellent long-term results.It may, however, be complicated by proximal stenosis of the re-implanted coronary arteries.

• Brand Name: PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NONABSORBABLE
• 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
• MDR Report Key: 7634720
• MDR Text Key: 112227289
• Report Number: 2210968-2018-73746
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K133356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/04/2018

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: 06/04/2018
• Initial Date FDA Received: 06/25/2018
• 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
• Patient Age: 59 YR