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

Catalog Number PSE45A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Death (1802)

Event Date 05/19/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).Batch # unk.Additional information received: device was fired on pulmonary artery and device performed normally (second firing with a white reload).Staples show a proper b-form.Heavy bleeding occurred.Suturing by hand was not successful.Device was fired over an existing staple line.Tissue was spongy, very soft and fragile.Surgeon thinks that the heavy bleeding and the death of the patient was not caused by the device but by the bad general condition of the patient.Pre-existing conditions: recurrent lung cancer in the dorsal left upper lobe.Lung cancer in the left lower lobe - ed (b)(6) 2014.Video-assisted mediastinoscopy (pius ol) - (b)(6) 2014.Left thoracotomy, resection of the lower lobe and radical lymphadenectomy (pius ol) (b)(6) 2014.Severe pain after surgery.Prolonged secretion after surgery.Pneumonia in the left upper lobe after surgery.Port implantation through the left cephalic vein (pius ol) (b)(6) 2014.Adjuvant chemotherapy (4 cycles of cisplatin and vinorelbine, pius ol) (b)(6) 2014.Two small, non-specific pulmonary masses in the right upper lobe.Copd severity iii, patient type c according to gold - ed 2011.Mild hypoxaemic insufficiency.Clinical history: basal-cell cancer of the left nasal wing.Resection (outpatient procedure) - (b)(6) 2013.Arterial hypertension.Nicotine abuse until 2004 (70 py).Surgical report: right lateral decubitus position, surgical washing and draping, team time-out.The thoracotomy scar was opened.Complete adhesion and syncretio of the upper lobe with the thoracic wall.Pleurolysis was carried out first (30 min).At the diaphragm, the tumour had grown into the parietal pleura and could not be separated from the diaphragm.I decided to resect the diaphragm.The inferior part of the upper lobe showed a firm infiltration.A slushy alteration was seen in its apical portion.Pleurolysis caused diffuse bleeding from the parietal pleurolysis area.Furthermore, increasing doses of arterenol were required due to septical infiltration to maintain an adequate circulation.Scarred adhesions were seen at the hilum.Therefore i opened the pericardium to intrapericardially visualize the pulmonary artery and the upper pulmonary vein.The central pulmonary artery was underpassed and bridled.After central closure of the artery with a white tx30 magazine, the upper pulmonary vein was underpassed and bridled and transected with a white echelon magazine.The pulmonary artery was again underpassed and the echelon was placed with a white magazine.Profuse haemorrhage occurred upon closure of the magazine.The magazine was shot off and an abdominal pad was used first to control the bleeding.Circulatory failure occurred due to the loss of blood and i started cardiac massage.The central pulmonary artery stump was inspected.The central row of sutures of the tx30 was found to be open.After placing a crawford staple, the arterial stump was closed again with a white tx30 magazine.Bleeding was stopped.After transfusion of four units of erythrocyte concentrate, temporary restoration of spontaneous circulation.Further preparation on the main bronchus.Another circulatory failure occurred and mechanical resuscitation was started once again.Sufficient circulation could not be restored in spite of large doses of catecholamine and mechanical resuscitation.After 45 minutes of resuscitation, the intervention was terminated at 5:24 p.M., also in view of the patient¿s malignant tumour disease and limited life expectancy.The wound was closed and dressing was applied to the wound.Additional information requested: are there any additional details regarding the alleged deficiency of the tx30v? regarding the ¿the central row of sutures of the tx30 was found to be open.¿ : were the staples properly formed but the tissue opened or were malformed staples noticed? does the surgeon believe the issue noted with the tx may have potentially caused or contributed to the patient¿s death? additional information received: i think there are some misunderstandings related to the translation of the additional info from the surgeon.However, when the pse45a (refer to (b)(4)) was closed at the vessel it was observed that the staple line of the tx30v at the pulmonary artery stump opened.The surgeon did not mention anything regarding misformed or insufficient staples of the tx30v staple line.The tissue condition was very bad due to the pre-op diagnosis of the patient.The surgeon complained the pse45a and not the tx30v.We will try to get a statement from the surgeon what might the most probable cause of this incident (device related or patient condition related).".

Event Description

It was reported that during an unknown procedure, the staple line was placed over an existing suture line.After application of a white reload there were bleedings from the pulmonary artery.Suturing was without success.The patient expired.The patient was operated on twice before, therefore he was already was in a bad condition.

Manufacturer Narrative

(b)(4).Batch # n5448c.The analysis found that one pse45a device was returned in good visual condition and with two ecr45w cartridges present.The reloads were received fully fired.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.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.

Manufacturer Narrative

(b)(4).Additional information received: after re-checking this case, it is possible that the echelon was placed and fired too close and tangential to the tx30 staple line and caused a tearing of staples.

• 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: 5729914
• MDR Text Key: 47585387
• Report Number: 3005075853-2016-03376
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K110385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: PSE45A
• Device Lot Number: N90X6G
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/20/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/16/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/28/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 62 YR
• Patient Weight: 64