MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC.; STAPLE, IMPLANTABLE

Catalog Number PVE35A

Device Problem Failure to Form Staple (2579)

Patient Problems Death (1802); Blood Loss (2597)

Event Date 12/17/2015

Event Type  Death  

Manufacturer Narrative

(b)(4).When additional information is received and/or the device analysis has been completed, a supplemental medwatch will be sent.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot/batch.Additional information received: the pve35a has been used at this account since (b)(6).With all successful outcomes.Indication for surgery was lung cancer.The patient was on heparin prior to surgery which was turned off at midnight.According to the surgeon, the pulmonary vein seemed a little thick but not excessive.There was a large tumor imbedded but was not at the vein margin but it is possible to have been partially in the lumen.When the device was fired, nothing out of the ordinary was noticed.When the device was opened, staples were noticed in the crotch area and distally but a 5-8mm hole was identified in the center of the staple line.It was stated that there might have been some tension on the vein during the firing as vessel loops were used to assist with visualization.On a previous firing of the device on the pulmonary artery, proper staple form and hemostasis was achieved.The patient lost approximately 4 liters of blood before gaining control of the bleeding.Per the sales rep: i was called into the room at the end but the patient had already passed away.I was shown the lung and i could see the hole in the vein.The surgeon stated that the tumor and the vein may have been too large for the load.The surgeon thinks that the device did not have anything to due to the event.

Event Description

It was reported that during a right vats video assisted thoracotomy, first fire was on the pulmonary artery.The staple line was clean and dry.The device was cleaned, swished and reloaded with the second reload.The device was fired to transect across the pulmonary vein.There were staples that formed in the very beginning and then there were no staples formed and then there were staples present and formed on the proximal tip.It is unknown if there were staples where the hole was because the patient started bleeding profusely.With all the suction, if they were there, they could have been suctioned out.They could not get control of the bleeding but they eventually did but the patient's heart had stopped.The patient expired.There was a huge tumor embedded in the vein.

Manufacturer Narrative

(b)(4).Batch # m55w7m.The analysis found that one pve35a device was returned in good visual condition and with three vasecr35 cartridge reloads present.The reload a was received unfired and in good visual conditions, reload b and c were received fully fired and in good visual conditions.The device was tested for functionality in the straight position with a test cartridge reload and achieved its complete firing sequence without any difficulties.The staple line and cut line were complete and the staples were noted to have the proper b-form shape.A batch record review was performed and no anomalies were found during the manufacturing process.

• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 5360421
• MDR Text Key: 35669501
• Report Number: 3005075853-2016-00216
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/13/2018
• Device Catalogue Number: PVE35A
• Device Lot Number: M93A45
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2016
• 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?: Yes
• Date Device Manufactured: 11/14/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1