MAUDE Adverse Event Report: COVIDIEN EVERFLEX+ SELF-EXPANDING PERIPHERAL STENT SYSTEM STANDARD; STENT, SUPERFICIAL FEMORAL ARTERY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Ischemia (1942); Myocardial Infarction (1969); Occlusion (1984); Renal Disease, End Stage (2039); Thrombus (2101)

Event Date 10/30/2017

Event Type  Injury  

Manufacturer Narrative

Society for vascular surgery 2018 4:1005-1016 ¿standard ¿off-the-shelf¿ multibranched thoracoabdominal endograft in urgent and elective patients with single and staged procedures in a multicenter experience¿.Event date is literature article published date.If information is provided in the future, a supplemental report will be issued.

Event Description

Journal of vascular surgery title: standard ¿off-the-shelf¿ multibranched thoracoabdominal endograft in urgent and elective patients with single and staged procedures in a multicenter experience objective: the objective of this study was to assess immediate and midterm outcomes for urgent/emergent and elective patients with thoracoabdominal aortic aneurysms (taaas) treated with the first commercially available ¿off-the-shelf¿ multibranched endograft for endovascular aneurysm repair, with a single-step or a staged surgical approach.Description: aortic endografts (proximal extensions, non-mdt endograft, and distal extensions, when needed) were implanted in the first step in most cases.After surgical exposure of the left subclavian, axillary, or brachial artery, bridging for visceral or renal vessels was performed with balloon-expandable or self-expanding covered stents.Relining with bare-metal stent (bms) was performed in case of short target vessel distal landing zone 20 mm) or covered stent kinking, and the decision for deployment was based on angiographic results.Bmss used included complete (medtronic, (b)(4)), protegé (covidien, (b)(4)), non-mdt stent, and everflex (covidien).No cases of intraoperative or intrasurgical stage mortality were registered.Successful bridging was performed in 98% of the target visceral vessel.Asymptomatic celiac trunk (ct) occlusion was observed in two elective patients treated with a staged approach (before bridging).Intentional renal artery occlusion was performed in four branches (urgent/emergent group) because of intraoperative thrombosis or technical impossibility to cannulate.In 93% one or more additional procedures were required to obtain complete aneurysm exclusion.Ct occlusion was treated with a plug and covered stent.Renal vessel occlusions were clinically associated with acute kidney injury (aki) in one patient (completely recovered), death in one patient (myocardial infarction), and no clinical sequelae in two patients.Immediate mortality was registered in three cases for myocardial infarction.Sci, spinal cord ischemia was reported for 2 patients directly after the procedure.Patients were promptly treated with cerebrospinal fluid drainage csfd, hypertensive therapy, and blood transfusion.3 cases of renal artery thrombosis were recorded, 1 required dialysis despite recanalisation.Other reinterventions included successful embolization of a type ii endoleak (transealing technique) and endovascular correction of a type ib endoleak.The overall aki rate was 21%.Dialysis was required in three cases temporarily and two perm anently.The two cases of permanent dialysis were associated with spontaneous cerebral bleeding and a single kidney with renal vessel occlusion.At 18 months, 8 deaths were reported due to sepsis, myocardial infarction, respiratory failure, multi organ failure after cerbral bleeding and hypovolemic shock.The rate of branch occulsion or stenosis was 1 %.A total of five late reinterventions were required in 5 patients.In addition to the two patients with branch occlusion, three patients required reinterventions for aneurysm sac reperfusion: one distal to the false lumen, one type ii endoleak, and one type iii endoleak.Seventy-three patients (274 tvvs) were enrolled.Treatment was performed in elective (n = 41 [56%]) or urgent/ emergent (n = 32 [44%]) settings, according to a single-step (n = 30 [41%]) or staged (n =43 [59%]) approach.Technical success was 92%.Mortality within 30 days was 4% (n = 3 urgent/emergent patients) due to myocardial infarction.Spinal cord ischemia was recorded in two patients (3%; elective group).The primary patency of tvvs was 99% (three renal branch occlusions).Procedure-related reinterventions were required in five cases (7%).At least one adverse event from any cause

• Brand Name: EVERFLEX+ SELF-EXPANDING PERIPHERAL STENT SYSTEM STANDARD
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): COVIDIEN; 4600n nathan lane; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600n nathan lane; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7640950
• MDR Text Key: 112420328
• Report Number: 2183870-2018-00360
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P110023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/27/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2018
• Initial Date FDA Received: 06/27/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR