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U.S. Department of Health and Human Services

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

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ETHICON INC. PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT; SUTURE, NONABSORBABLE Back to Search Results
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.
 
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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 Key7634720
MDR Text Key112227289
Report Number2210968-2018-73746
Device Sequence Number1
Product Code GAW
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K133356
Number of Events Reported1
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 Received06/25/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age59 YR
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