MAUDE Adverse Event Report: COVIDIEN ABRE VENOUS SELF-EXPANDING STENT SYSTEM; STENT, ILIAC VEIN

Model Number AB9U18060090

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Pain (1994); Tachycardia (2095); Swelling/ Edema (4577)

Event Date 05/14/2021

Event Type  Death  

Manufacturer Narrative

Image review: three photographs of cine images, one photograph of cat image, and a cross section video were provided for analysis.The images are from the implant procedure.The first image is of a pta device being inflated in the patient¿s proximal superior vena cava.The second image is of the abre stent implanted in the patient¿s proximal superior vena cava.The third image is a post-implant inflation of a pta device within the implanted abre stent in the patient¿s proximal superior vena cava.The fourth image is from a cat scan and the abre stent does not appear to have fully expanded along its total length in the proximal superior vena cava.At three points in the cross-section video annotated arrows are used to high light certain section of the implanted abre stent.In the cross-section video the abre stent appears to be fully expanded in the targeted vessel anatomy.If information is provided in the future, a supplemental report will be issued.

Event Description

Physician used an abre self-expanding venous stent system with a 9fr non-medtronic short sheath and 0.035 floppy end guidewire during treatment of a 20mm cto (chronic total occlusion-100%) in the patient¿s proximal superior vena cava (svc) due to a previously placed standard infusion port which was removed approximately 2.5 weeks prior.Vessel diameter is reported as 16mm.The patient had previously been taking anti-coagulants but had not been medicated for 2 days prior to the procedure.Medications used during the procedure reported as 3mg versed, 15mcg fentanyl and 50mg benadryl.Conscious sedation was performed and monitored.Limited ultrasound of the neck and right groin revealed patent jugular and common femoral veins (cfv).The patient was prepped and draped in the usual fashion.Under ultrasonographic guidance a micro puncture kit was used to access the cfv.A 0.018" guidewire was advanced into the vena cava.The needle was then exchanged for a 4fr micro puncture sheath.Internal dilator and wire were removed, and non-medtronic 0.035" guidewire was advanced into the inferior vena cava.The micro puncture sheath was exchanged for a 10fr flush sheath.In similar fashion, the right internal jugular vein was accessed under direct ultrasonographic guidance.Initial central venogram revealed no antegrade flow through the svc.Venous return to the right heart via a dilated tortuous azygos vein.The svc obstruction was recanalized from an inferior approach.A non-medtronic (amplatz) wire was positioned in the patent portion of the jugular vein.Using a 10mm endovascular snare, the wire was retrieved and through and through access was established.Intravascular ultrasound was utilized when delineated a short segment of approximately 100% superior vena cava occlusion.Angioplasty of svc with 12mm balloon was performed.Pre-dilation was performed with a 14mm device prior to use of the abre venous stent.The physician was informed this was an off-label use for the device prior to conducting the procedure.The device did not have to pass through a previously deployed stent.No resistance was noted during advancement of the device and no excessive force was used.The stent was implanted across the stenosis without difficulty.Post dilation was performed using a 18mm balloon.Central venogram revealed brisk antegrade flow through the svc and into the right atrium.Post stent intravascular ultrasound revealed excellent wall apposition.Final run via fluoro and ivus confirmed that vessel was open, and procedure was successful.The wire was removed followed by the sheaths.Hemostasis was rapidly achieved with manual compression and sterile bandages were applied.Estimated blood loss during the procedure 20ml.No complications were noted immediately post-procedure and the patient was discharged home.The patient had not restarted anti-coagulant therapy following the stent implant.The patient arrived at the emergency department with a small pericardial effusion later that evening (18:30).The patient experienced symptoms of extreme abdominal pain, hypertension, and tachycardia.The patient is reported to have coded approximately 9 hours later (03:15).Physician attended medical icu 7 mins later and was informed the patient was in extremis.The patie nt was receiving cpr and pulseless electrical activity.Pericardiocentesis was attempted using the subxiphoid position and the left fourth interspace position.There was blood in the fluid.Approximately 100ml of fluid was aspirated each time but did not relieve the pulseless electrical activity.A surgical team arrived and prepped the patient with betadine.Drapes were applied.A scalpel was used to make an incision through the upper abdomen and rectus.Bandages scissors were used to excise the xiphoid.The pericardium was cut, and then grasped with a ochsner clamp and incision enlarged.500ml of fluid was evacuated from the pericardial space and the heart felt empty and the rate of drainage was not decreasing, and the patient was in pulseless electrical activity.Decision was made to perform and emergency sternotomy.The sternum was opened in the midline with a reciprocating saw.The blood was evacuated from the pericardium.Open cardiac massage was performed, and perfusing rhythm was regained.Continuous bleeding was observed from the pericardiotomy.The svc was visualised at stent and was felt through the wall of the svc and retracted the aorta and there was continuous bleeding from the svc.Pericardial was well developed.A pericardial patch was sutured about the area of the perforation which caused the perforation to be hemostatic.This was running with a 4-0 prolene suture.A laceration was observed in the aorta that was adjacent to the strut which was sticking through the svc.This was repaired with 2 figure-of-eight 4-0 prolene sutures.The patient entered an agonal rhythm.It was suspected the sutures being close to the sa node caused heart block so temporary pacing wires were placed on the ventricle.There was minimal wall electrical capture which progressed to no electrical capture even after volume resuscitation with open cardiac massage.Given the massive blood loss and an inability to maintain cardiac rhythm and a heart that was becoming increasingly pale and edematous, it was identified that there was no surviving the situation.The sternum was reapproximated with a sternal wire and the skin with staples and time of death was pronounced at 5am.The cause of death is reported as being due to massive blood loss due to a lacerated aorta.

• Brand Name: ABRE VENOUS SELF-EXPANDING STENT SYSTEM
• Type of Device: STENT, ILIAC VEIN
• 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: 11900561
• MDR Text Key: 253132105
• Report Number: 2183870-2021-00198
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 00643169796386
• UDI-Public: 00643169796386
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2023
• Device Model Number: AB9U18060090
• Device Catalogue Number: AB9U18060090
• Device Lot Number: B068740
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/14/2021
• Date Device Manufactured: 08/12/2020
• 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): Death; Required Intervention
• Patient Age: 37 YR
• Patient Weight: 107