MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2020-03-26 for ZENITH ALPHA? THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS ZTA-PT-46-42-179-W1 manufactured by William Cook Europe.
[185001008]
Manufacturers ref# (b)(4).? Similar to device under pma/510(k): p140016. (b)(4). Investigation is still in progress.
Patient Sequence No: 1, Text Type: N, H10
[185001009]
Description of event according to initial reporter: emergency tevar was performed on a (b)(6) year old male patient to treat the rupture of a thoracic aorta aneurysm. The patient was suitable for the procedure. Tevar + 2 debranch (ax-ax-left common carotid artery) was selected in consideration of old age ((b)(6) years old), experience of perkutan coronar intervention (pci) and because the state of rupture was stable. After performing 2 debranch, the left femoral artery (fa) was cut down and a 8fr sheath was inserted. After advancing another manufacturers wire guide to the ascending aorta, a pigtail catheter with a marker was advanced to the ascending aorta over the wire guide, then the wire guide was replaced with medicos hirata? S egoist. While, a 5fr sheath was inserted from the left subclavian artery (lsca), then terumo? S radifocus was advanced to the ascending aorta and a pigtail catheter with a marker was advanced over the wire guide. Angiography confirmed state of the branch of the aortic arch, bypass and the location of to-be-placed stent graft. The delivery system of zta-de-38-91-w1 was inserted from the left fa and the stent graft was deployed in the descending aorta successfully with performing angiography. Next, the zta-pt-46-42-179-w1 was inserted to be placed above (proximal side of) the zta-de-38-91-w1. After the location was checked with angiography, the stent graft was deployed with performing? Rapid pacing?. Though the inner curvature side of the stent graft was deployed bent, it was resolved by ballooning with medtronic? S reliant and the stent graft could be placed in a desired shape. (blood pressure was confirmed to be lower at this time, so rapid pacing was not being performed. ) the blood pressure kept dropping from then. Coiling was conducted in the lsca because the physician thought that type 2 endoleak occurred by retrograde blood flow from the lsca. Since the blood pressure did not rise, rtad (retro- grade type a aortic dissection) was suspected, but it was not confirmed with angiography. Fluid retention inside the intrathoracic space was confirmed with transesophageal echocardiography (tee), so thoracic drainage was conducted with a trocar catheter and much amount of blood was drained. Blood infusion and cardiac massage were performed, but no improvement could be seen. Pcps (percutaneous cardiopulmonary support) was also used, but it did not help. The physician thought that the bleeding (rapture point) was not arrested and suspected an endoleak. The extension and mainbody were placed with 2 stents overlap, so another extension zta-de-46-97-w1 was additionally placed in the junction part to resolve a possible type 3a endoleak. Angiography performed after that confirmed an endoleak and the physician judged it as type 4. Pupillary enlargement was observed and the amount of thoracic drainage did not decrease, then the patient was confirmed to be dead. Additional information provided: on (b)(6) 2020, the (b)(6) year old male patient had a breathing problem in the morning and went to the hospital. Hemodynamic status was stable when the patient arrived at the hospital, but because left pleural effusion was confirmed with simple ct and the pleural effusion was bloody, he was diagnosed with rupture of taa and transferred to another hospital with stable hemodynamics. When the patient arrived at the hospital, he stayed awake and alert. The patient was suitable for the procedure. Tevar with two stent grafts (in distal side first, the proximal side next) + 2 debranch (ax-ax-left common carotid artery) was selected in consideration of old age ((b)(6) years old), experience of perkutan coronar intervention (pci) and because the state of rupture was stable. Although open aortic arch replacement + open stent graft placement could have been selected, we had no suitable sized device in our stock. If the patient were young, i would have selected open aortic arch replacement. The patient family requested an operation after explanation of the operation by the physician. They entrusted the physician with the method. [procedure prior to sudden changes in the patient condition] 2 debranch + emergency tevar was performed on the (b)(6) year old male patient to treat the rupture of a thoracic aorta aneurysm on the day at 20 o? Clock. After performing 2 debranch with heparin administration, the left femoral artery (fa) was cut down and an 8fr sheath was inserted. After advancing another manufacturers wire guide to the ascending aorta, a pigtail catheter with a marker was advanced to the ascending aorta over the radifocus, then the wire guide was replaced with medicos hirata? S egoist. The physician did not experience any difficulty in manipulation of wire guides. While, a 5fr sheath was inserted from the left subclavian artery (lsca), then terumo? S radifocus was advanced to the ascending aorta and a pigtail catheter with a marker was advanced over the wire guide. Angiography confirmed state of the branch of the aortic arch and the location of to-be-placed stent graft and also that ax-ax-lcca bypass was patent. The delivery system of zta-de-38-91-w1 was inserted from the left fa and the stent graft was deployed in the descending aorta successfully with performing angiography. Next, the zta-pt-46-42-179-w1 was inserted to be placed above (proximal side of) the zta-de-38-91-w1. After the location was checked with angiography, the stent graft was deployed with performing? Rapid pacing?. Though the inner curvature side of the stent graft was deployed bent, it was resolved by ballooning with medtronic? S reliant and the stent graft could be placed in a desired shape. (blood pressure was confirmed to be lower at this time, so rapid pacing was not being performed. ) usually, blood pressure of upper extremity rises and that of lower extremity drops during balloon inflation then the pressure becomes normal again after balloon deflation. During ballooning to resolve the bend, the blood pressure followed the usual movement. The second ballooning was performed between the junction of the two stent grafts, but after that, the blood pressure of the upper and lower extremities dropped and the patient went into shock and suffered cardiopulmonary arrest (pea). Resuscitation was performed. [procedure after sudden changes in the patient condition]. The physician thought that type 2 endoleak occurred by retrograde blood flow from the lsca and it resulted in taa re-rupture and a blood flow into the pleural space. He blocked the flow from the proximal side of the anastomotic part of bypass in the left ax with performing fluid replacement and blood infusion and conducted coiling quickly in the lsca. However, because these treatments did not help, pcps was used. Fluid retention inside the intrathoracic space was confirmed with transesophageal echocardiography (tee), so thoracic drainage was conducted with a trocar catheter and much amount of blood was drained. The physician tried to control the bleeding with cell saver though, it did not help and neither did pcps. Angiography could not confirm obvious endoleak due to weak blood flow. Rtad (retro- grade type a aortic dissection) was suspected, but it was not confirmed with angiography. Cardiac tamponade was not observed. There was no problem observed in the landing state of the proximal and distal stent grafts, but because type 3a endoleak (from junction) was suspected due to 2 stents overlap, another extension zta-de-46-97-w1 was additionally placed in the junction part. Resuscitation was performed more than 60 minutes, but spontaneous circulation was not returned and pupillary enlargement was observed. Resuscitation was abandoned and the patient was confirmed to be dead at 22:50. Confirmatory angiography was performed by sending blood through pcps with the stent graft filled with contrast media, then endoleak from the stent graft itself was suspected, which looked more likely to be type 4 endoleak, but still there was a possibility of type 3b (damage in the graft). However, the type of endoleak could not be determined since autopsy was not conducted without consent from the patient family. Patient outcome: the patient expired.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002808486-2020-00366 |
| MDR Report Key | 9882418 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-15 |
| Date Mfgr Received | 2020-03-15 |
| Device Manufacturer Date | 2019-04-30 |
| Date Added to Maude | 2020-03-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. THOMAS HESSNER KIRK |
| Manufacturer Street | SANDET 6 |
| Manufacturer City | BJAEVERSKOV DK-4632 |
| Manufacturer Country | DA |
| Manufacturer Postal | DK-4632 |
| Manufacturer Phone | 56868686 |
| Manufacturer G1 | WILLIAM COOK EUROPE |
| Manufacturer Street | SANDET 6 |
| Manufacturer City | BJAEVERSKOV DK-4632 |
| Manufacturer Country | DA |
| Manufacturer Postal Code | DK-4632 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZENITH ALPHA? THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS |
| Generic Name | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
| Product Code | MIH |
| Date Received | 2020-03-26 |
| Catalog Number | ZTA-PT-46-42-179-W1 |
| Lot Number | E3846130 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WILLIAM COOK EUROPE |
| Manufacturer Address | SANDET 6 BJAEVERSKOV 4632 DA 4632 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-03-26 |