MAUDE Adverse Event Report: WILLIAM COOK EUROPE ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number ZTA-P-22-105

Device Problem Occlusion Within Device (1423)

Patient Problems Abdominal Pain (1685); Thrombosis (2100); Paraplegia (2448)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Cook medical incorporated (cmi).(b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: "thrombosis of the thoracic graft.On (b)(6) 2015 the patient arrived at the hospital in urgency for a thoracic rupture at the isthmus region, treated with a 22mm alpha thoracic graft.Dismissed with cardio aspirin therapy.On (b)(6) 2016 the patient has been hospitalized in urgency for abdominal pain, paraplegia and renal failure.The ct scan showed a complete thrombosis of the terminal part (distally) of the thoracic endograft involving a part of the aorta.After the first implant ((b)(6) 2015) the patient has been discontinuous with the drug intake (cardio aspirin) and for this reason the physician connected the thrombosis at this fact.Seeing what happened the physician decided to do a relining of the previous graft with another one, also 22mm and everything has gone well with a disappearance of abdominal pain related to a mesenteric ischemia.Permanence of the paraplegia (validation by a rm of a marrow damage).On (b)(6) 2016 ct scan control ok.On (b)(6) 2017 ct scan control ok.On (b)(6) 2017 ct scan control with a validation of a new thrombosis in the terminal part of the thoracic graft implanted.Patient outcome: the patient required an additional procedures due to this occurrence."relining of a thoracic graft with another one to solve the first thrombosis and explanation of the both grafts to definitively solution of this complex trouble on (b)(6) 2017".According to the initial reporter, the patient did experience adverse effects due to this occurrence."open surgery explanation of the devices in situ".

Manufacturer Narrative

Exemption number e2016032.(b)(4).Manufacturers ref# (b)(4).Journal article: "hypertension, acute stent thrombosis, and paraplegia 6 months after thoracic endovascular aortic repair for blunt thoracic aortic injury in a (b)(6)-year-old patient" by martinelli et al, 2017.(b)(4).Investigation is still in progress.

Event Description

Additional information received 14may2018: per journal article: almost 6 months later, the patient presented to the emergency department with paraplegia, acute malperfusion syndrome with acute renal failure, and abdominal pain.He reported that he had not been compliant with the therapy.Whole-body cta scan was performed revealing thrombosis of the aortic lumen at the distal edge of the endograft.Spinal cord magnetic resonance showed an acute ischemic injury of the spinal cord at d11-d12 level.An endovascular relining was decided.The patient referred that he had taken the aspirin days before and was not sure of the date.The risk for spinal haemorrhage was elevated.Owing to the nonreliability of the patient, it was decided to not place any spinal catheter.The left femoral artery was exposed and used as the main access vessel.Percutaneous access was performed to the right femoral artery.A zenith cook alpha (cook incorporated, bloomington, in) 22 mm _ 100 mm was used for the procedure.Final angiography showed graft patency and no residual stenosis.In the postoperatory period, the patient showed resolution of the malperfusion syndrome.Paraplegia persisted.Hypertension persisted and was treated with 4 different antihypertensive drugs.Angio-ct control documented the proper positioning of the devices, no infoldings, and the optimal filling of the thoracic aorta downstream of the endoprosthesis.Patient outcome: additional information received 14may2018: according to the initial reporter, the patient did experience adverse effects due to this occurrence.Per journal article: paraplegia, acute malperfusion syndrome with acute renal failure, and abdominal pain.In the postoperatory period, the patient showed resolution of the malperfusion syndrome.Paraplegia persisted.

Manufacturer Narrative

Exemption number e2016032.(b)(4).Manufacturers ref# (b)(4).Name and address for importer site: (b)(4).This device size is part of recall z-2099-2017 of jun2017.For this event, the device was used for thoracic rupture and was implanted prior to the recall of the device.Vice.Summary of investigational findings: thrombosis inside stent graft is reported in this complaint file.Pre-implantation cta, one day post-implantation cta and a six-month post-implantation cta of the initial stent graft are provided.The six-month cta was performed secondary to ischemic symptoms and soon afterward the second stent graft was implanted.As per imaging review, intra-graft thrombus of each implanted stent graft is confirmed.Although not occlusive, the ischemia causing thrombus resulted in enough pressure drop to collapse the aorta just downstream.The aorta lengthened and settled after each endograft although with the first an aortic fold at the endograft distal end was not observed.The sheet-like thrombus developed in each distal graft.Thrombus location relative to the aorta and the graft, specifically in the mid to distal descending thoracic aortic graft two to three stent bodies proximal to the distal end, is similar to other cases.The reduction in outflow diameter is similar to other reviewed cases.In this case, the distal diameter reduction was initially from a completely expanded endograft larger than the adjacent native artery and then later from a fold caused by aortic settling.Internal actions have been initiated previously.It is noted that the device was used outside of intended use as the blunt thoracic aortic injury indication was not part of the indication use for this device back in 2015.Cook medical will continue to monitor for similar events.

Manufacturer Narrative

Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturers ref# (b)(4).Name and address for importer site: cook medical incorporated (cmi) (b)(4).Registration no.: (b)(4).Ec method code: 4109 - historical data analysis.4112 - analysis of data provided by user/third party.4117 - device not accessible for testing.Ec conclusion code: 4315 - cause not established.Summary of investigational findings: the article was reviewed and provides no additional information that change the findings in previous investigation submitted on 28feb2018.The patient outcome and explantation date describe that the stent grafts (in pr210590 and pr210591) were explanted in (b)(6) 2017 by open surgery.As referred to in the previous investigation, this complaint falls under the scope of internal actions.Cook medical will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 7150443
• MDR Text Key: 95897620
• Report Number: 3002808486-2017-02520
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002346755
• UDI-Public: (01)10827002346755(17)161024(10)E3148215
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/03/2018

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
• Device Expiration Date: 10/24/2016
• Device Catalogue Number: ZTA-P-22-105
• Device Lot Number: E3148215
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/05/2017
• Initial Date Manufacturer Received: 12/05/2017
• Initial Date FDA Received: 12/28/2017
• Supplement Dates Manufacturer Received: 02/08/2018; 05/14/2018; 08/10/2018
• Supplement Dates FDA Received: 02/28/2018; 05/29/2018; 09/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2099-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 22 YR