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

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

Patient Problems Stroke/CVA (1770); Hematoma (1884); Hemorrhage/Bleeding (1888); Hypoxia (1918); Unspecified Infection (1930); Ischemia (1942); Pneumonia (2011); Renal Failure (2041); Obstruction/Occlusion (2422); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/01/2021

Event Type  Injury  

Manufacturer Narrative

Title: early and midterm results from a postmarket observational study of zenith t-branch thoracoabdominal endovascular graft author: michel bosiers, tilo kölbel, timothy resch journal: journal of vascular surgery year: 2021 vol/issue: vol 74, issue 4 ref: doi.Org/10.1016/j.Jvs.2021.01.070.Average age.Majority gender.Date of publication journal reported death but there is no information to suggest the device caused or contributed to the death events.Deaths are common occurrences in clinical studies, however the cause(s) of death are often not characterized or clearly associated with a particular product.Therefore, deaths will not be considered reportable unless clearly stated as being associated with a medtronic device.

Event Description

A journal article was submitted reporting the short-term outcomes regarding the safety of the an off-the-shelf non-medtronic t-branch multibranched thoracoabdominal stent-graft in a post market, multicentre study.The primary objective of the present study was to assess the procedure-related mortality and morbidity at 30 days.The secondary objectives included the assessment of 1-year mortality and morbidity, device integrity, procedural outcomes (including successful access and deployment of the graft), patency of the graft and bridging stent-graft (bsg), endoleaks, aneurysm growth, and secondary procedures at follow-up.80 patients were included in the study.77 patients were treated for thoracoabdominal aortic aneurysms (taaas) and the rest (3) for dissection.Overall, covered stents had been placed in 68 cas, 79 smas, 76 rras, and 74 lras.Uncovered stents had been placed in 49 cas, 65 smas, 53 rras, and 49 lras as reinforcement or to create a smooth transition with the target vessel.After complete deployment of the endografts, all target vessels were cannulated through their respective branches via trans-brachial or axillary access.The 8f sheath was advanced into the vessel orifice over a wire using an atraumatic j-tip with a balloon or flexible dilator.One or more balloon-expandable co vered stents (becss) or self-expandable covered stents (secss) were then used as bsgs.In other patients, when a secs was used as a bsg requiring a larger 10f or 12f sheath, the sheath was placed just proximal to the branch, and the secs was then deployed.At the operator¿s discretion, additional uncovered stents were used to create a smooth transition or as reinforcement.Of the stents used during the procedure¿s medtronic¿s complete se, everflex, and visipro stents were implanted.1 patient is reported to have died on postoperative day 30 of multiorgan failure.At 1 year, seven additional patients had died.Of various reasons, including hypoxia, myocardial infarction, sepsis, hemorrhagic shock, stroke, heart failure, and unknown in one patient each.No aortic ruptures or conversions to open surgery had occurred during follow-up.Early neurologic events occurred in 10 patients.Three patients had experienced a stroke.In two of the patients, the symptoms had resolved after 4 or 19 days, and in one patient, the neurologic deficit remained present at 30 days after the procedure.Spinal cord ischemia (sci) occurred in 7 of the 80 patients.Of these seven patients, one had experienced paraplegia on postoperative day 1 and six had experienced paraparesis, which had developed postoperatively in three patients and within the first week in three patients.Data on the severity and symptoms of the neurologic events were not collected, although 8 of 10 patients with neurologic events had required prolonged hospitalization.Early renal failure requiring dialysis occurred in two patients on postoperative days 0 and 5.Both patients required intermittent hemofiltration or hemodialysis.Renal insufficiency occurred in two patients.One patient experienced bilateral renal branch occlusion on postoperative day 24.This patient had had an unknown heparin-induced thrombocytopenia type ii and underwent successful endovascular thrombectomy.In both renal arteries, a becs was used with a secs for relining.The other patient had experienced renal insufficiency after 3 days and was treated with hydration.During follow-up, one additional patient experienced right renal branch occlusion on postoperative day 207 and was treated with endovascular thrombectomy and stent placement.Secondary interventions were performed in 4 of the 79 patients within 30 days and in 9 patients within 1 year.All secondary interventions were performed endovascularly, including the renal branch thrombectomy, stent placement for a stenosed ca, stent placement for a stenosed left hypogastric artery, endograft placement for a typeia endoleak, and stent placement or balloon angioplasty for a bsg-related endoleak.During follow-up, three bsgs for the ca had become occluded but did not require reintervention.Right renal stent compression was observed in 1 of 79 patients without requiring intervention.Three patients showed an increase of >5 mm in aneurysm size after 1 year.Two patients had developed type ii endoleaks.One patient was treated with coil embolization after 1 year and was subsequently lost to follow-up; the other patient was never treated and remained stable.The remaining patient with aneurysmal growth had a type iii endoleak resulting from a broken ca covered stent and underwent treatment after 12 months.The latter patient died shortly after treatment with a covered stent.Early type ii endoleaks had developed in 30 of 72 patients.At 1 year, the endoleaks had resolved spontaneously in 14 of these patients.None of these patients had required treatment within the first year.Of the 72 patients, 4 had had a proximal type ia endoleak.One patient was treated with thoracic endograft extension placement, and the endoleak had spontaneously resolved in another patient.No further ct evaluations were available for 1 patient during the study period for unknown reasons.In the fourth patient, the ct findings after 6 months reported only a type ii endoleak, indicating that the type 1a endoleak could have been misinterpreted or that it had spontaneously resolved.Of the 72 patients, 6 had had early type iii endoleaks.Two of these endoleaks (both of which resolved spontaneously) were between the main body endografts, two were associated with a branch or limb left open intentionally to prevent sci (and had been treated after a few weeks), one was present at an intentionally occluded renal branch, and one was at an unknown location.At 1 year, type iii endoleaks were observed in four patients.In three patients, treatment was performed for these endoleaks with balloon angioplasty and/or additional stent placement.There is no established or suspected causal relationship between the device(s) and the death events.

• Brand Name: EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM STANDARD
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12873663
• MDR Text Key: 285992224
• Report Number: 2183870-2021-00429
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P110023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/25/2021

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: 11/15/2021
• Initial Date FDA Received: 11/25/2021
• 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; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male