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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. VICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC

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ETHICON INC. VICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Anemia (1706); Hemorrhage/Bleeding (1888); Hernia (2240); Not Applicable (3189)
Event Type  Injury  
Manufacturer Narrative

(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. Citation: case reports in medicine (2010) 1-3; doi:10. 1155/2010/213818. (b)(4).

 
Event Description

Title : acute tension pneumothorax following cardiac herniation after pneumonectomy this case report presented a (b)(6)-year-old woman (height 156 cm, weight (b)(6) kg), showed symptoms of chronic cough, recurrent pulmonary infections, and pronounced stress dyspnea. Further evaluations revealed tuberculosis, treated several years with an unknown monotherapy. The respiratory function test indicated marked restricted lung function. A chest ct scan revealed right accentuated severe bronchiectasis accompanied by pulmonary emphysema. During a rigid bronchoscopy, a damage of the right main stem bronchus and massive purulent secretions of the right caudal lung sections (affected by escherichia coli) were found. Lung ventilation-perfusion scintigraphy showed a distribution of ventilation of 90% on the left and 10% on the right side. Thus, decision for right pneumonectomy was made. Pneumonectomy was performed through a lateral thoracotomy. To reduce the risk of postoperative bronchial stump dehiscence, the bronchial stump was covered with a pedicled pericardial flap, and the pericardial defect was immediately repaired with a vicryl mesh (ethicon). A chest tube was placed in the right cavity. At the end of surgery, the patient was successfully extubated and transferred to the intensive care unit. A few hours later, the patient became hemodynamically unstable and showed an anemia (hb: 6. 7 g/dl). Because of an assumed intrathoracic hemorrhage and possible cardiac herniation, the patient was taken back to the operating room. On reopening of the thoracotomy, cardiac herniation into the right thoracic cavity because of a rupture of the vicryl mesh was seen. Surgical treatment included suture of the pulmonary vein and left atrium as well as repair of the pericardium with a gore-tex patch with an excellent postoperative result. In summary, this study presented the successful treatment of a patient with an acute tension pneumothorax following cardiac herniation and intrathoracic bleeding after pneumonectomy. Immediate re-thoracotomy and needle thoracocentesis are essential procedures in such circumstances and should be conducted without delay.

 
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Brand NameVICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
Manufacturer (Section G)
ETHICON INC.-GMBH
robert-koch strasse 1
norderstedt D2285 1
GM D22851
Manufacturer Contact
kara ditty-bovard
p.o. box 151, route 22 west
somerville, NJ 08876
6107428552
MDR Report Key9567055
MDR Text Key189330791
Report Number2210968-2020-00215
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK810428
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,L
Reporter Occupation
Type of Report Initial
Report Date 12/13/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/08/2020
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/13/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/08/2020 Patient Sequence Number: 1
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