MAUDE Adverse Event Report: MEDTRONIC IRELAND COMPLETE SE ILIAC; STENT, ILIAC

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

Patient Problems Aneurysm (1708); Myocardial Infarction (1969); Reocclusion (1985); Pneumonia (2011); Renal Failure (2041); Heart Failure (2206); Patient Problem/Medical Problem (2688)

Event Date 03/12/2019

Event Type  Injury  

Manufacturer Narrative

Age or date of birth: average age.Sex: majority gender.Date of event: date of publication journal article.Title: "midterm results with the open chimney technique during endovascular aneurysm repair." © 2019 published by elsevier, inc., on behalf of sir.J vasc interv radiol 2019; 30: 511¿520.Https://doi.Org/10.1016/j.Jvir.2018.09.013.If information is provided in the future, a supplemental report will be issued.

Event Description

This article reports on the midterm experience with chimney-endovascular aneurysm repair (ch-evar) with the use of open self-expending stents for branch vessel preservation.Procedures were performed in the operating room under general anaesthesia and systemic heparinization (0.5 mg/kg).Briefly, the aortic graft was introduced from a femoral access.A bare ses was placed into the target vessel from an upper brachial access over a superstiff 0.035¿¿ wire.Chimney grafts were chosen to extend " 1 cm above the covered part of the aortic graft into the free-flow section, as per the actual instructions for use of the european conformity-mark approval and to leave " 2 cm within the target vessel.The median diameters of the open chimneys were 9 mm and 6 mm with a median length of 60 mm and 40 mm for the sma and the renal arteries, respectively.Complete se devices were used during procedures.Complete se stents were preferred because of enhanced visibility and a triaxial design, which stabilizes the sheath by reducing friction forces and ultimately leads to an easier and more accurate deployment of the chimney.A significantly greater degree of oversizing was also applied to the aortic graft during the later period in reaction to prior investigations to allow the fabric to mold around the chimneys and limit the risk of type ia endoleaks.After extrinsic compression due to device-to-device and device-to-vessel interaction was reported for 2 patients in the early period of this study, open chimneys were strengthened by a second ses of the same diameter and length to increase their radial force.The endovascular repair was also extended to more complicated designs.Every renal artery or sma close to the proximal landing zone was considered a target artery, and a kissing balloon technique was not used since the implanted stents were only sess.No procedure-related deaths or open conversions were reported, and every target vessel was successfully reconstructed.According to the reporting standard 10 mild, 7 moderate, and 7 severe complications developed in 32.8% of patients.The in-hospital and early postoperative (30-day) mortality rate was 9%.Patients died of heart failure, myocardial infarction, pneumonia, multiple organ failure, and stroke.Six patients died during the follow-up, of heart failure, pneumonia, and aneurysm-related.Estimated 2-year primary patency of open chimneys was 95.2%.There were 4 occlusions of open chimneys to the renal arteries.During the early period, 1 occlusion was incidentally discovered 2 days after the initial procedure on the control ct scan in a patient already on dialysis; and 1 occlusion occurred at 1 month in a patient who suddenly suffered from anuria and neurologic degradation after a cardio-embolic event and died in the aftermath.During the later period, 2 patients manifested by acute flank pain 17 days and 1 month after the initial procedure, respectively, which both led to a failed attempt to rescue them, leading to a severe deterioration of the renal function and dialysis in the first patient.The second patient did not exhibit any long-term consequence.Eight renal infarcts were observed over 9.0% of patients.The patient in the early group, who presented with bilateral renal infarcts, had a ¿shaggy¿ distal aorta, and the postoperative ct scan showed multiple distal emboli in the territory of both renal and splenic arteries despite a preserved patency of the main branches.His renal function showed significant improvement during follow-up.Two of 12 patients experiencing acute kidney injury required temporary dialysis, and 2 required permanent dialysis.

• Brand Name: COMPLETE SE ILIAC
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8600236
• MDR Text Key: 144719209
• Report Number: 9612164-2019-01666
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P090006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• 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
• Date Manufacturer Received: 04/17/2019
• 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: 77 YR