MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ELUVIATM DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Device Problem Migration (4003)

Patient Problems Death (1802); Perforation (2001); Perforation of Vessels (2135); Blood Loss (2597)

Event Date 07/31/2018

Event Type  Death  

Event Description

The patient was enrolled in (b)(6) study.It was reported that a stent migration occurred which resulted in patient death.On (b)(6) 2018, the patient was noted to have bilateral claudication.On (b)(6) 2018, duplex ultrasound revealed recurrent stenosis in the right proximal superficial femoral artery (sfa) and external iliac artery.The stenosis in the right sfa was treated with pre-dilatation.After pre-dilatation, a dissection was noted.The dissection was then treated using a 6mm x 80mm eluvia stent.The lesion was then post-dilated with a 5mm x 80mm balloon without residual stenosis.Spasm was noted in the sfa and was treated with continued percutaneous transluminal angioplasty (pta).The restenosis in the left external iliac artery was then treated with a 6mm x 80mm eluvia stent.Post treatment, the lesion was post-dilated with a 5mm x 80mm balloon.During the procedure, post endovascular intervention, a drop in hemoglobin and bloated abdomen was noted and bleeding was suspected from the retroperitoneum.The patient's pressured dropped and had ecg changes, so exploration via the left side of the groin puncture was performed and evaluation revealed the eluvia stent placed in the left external iliac artery had migrated, and massive blood loss was noted due to the migration of the stent, and the stent perforating the external iliac artery.The stent was extracted through open surgery and the external iliac artery was closed.A blood transfusion was also performed.The patient was transferred to the intensive care unit (icu).Despite extensive resuscitation and recovery of blood vessel, the patient died at the icu.The primary cause of death is bleeding from the external iliac artery, perforated by the stent.

Manufacturer Narrative

Device is a combination product.

Event Description

The patient was enrolled in the (b)(6) study.It was reported that a stent migration occurred which resulted in patient death.On (b)(6) 2018, the patient was noted to have bilateral claudication.On (b)(6) 2018, duplex ultrasound revealed recurrent stenosis in the right proximal superficial femoral artery (sfa) and external iliac artery.The stenosis in the right sfa was treated with pre-dilatation.After pre-dilatation, a dissection was noted.The dissection was then treated using a 6mm x 80mm eluvia stent.The lesion was then post-dilated with a 5mm x 80mm balloon without residual stenosis.Spasm was noted in the sfa and was treated with continued percutaneous transluminal angioplasty (pta).The restenosis in the left external iliac artery was then treated with a 6mm x 80mm eluvia stent.Post treatment, the lesion was post-dilated with a 5mm x 80mm balloon.During the procedure, post endovascular intervention, a drop in hemoglobin and bloated abdomen was noted and bleeding was suspected from the retroperitoneum.The patient's pressured dropped and had ecg changes, so exploration via the left side of the groin puncture was performed and evaluation revealed the eluvia stent placed in the left external iliac artery had migrated, and massive blood loss was noted due to the migration of the stent, and the stent perforating the external iliac artery.The stent was extracted through open surgery and the external iliac artery was closed.A blood transfusion was also performed.The patient was transferred to the intensive care unit (icu).Despite extensive resuscitation and recovery of blood vessel, the patient died at the icu.The primary cause of death is bleeding from the external iliac artery, perforated by the stent.It was additionally reported that the vessel was minimally tortuous with no calcification.It was also reported that the stent migrated distally and perforated the anterior wall of the artery.

Manufacturer Narrative

Device is a combination product.Bsc medical director reviewed the media as part of the investigation of the reported event.This review revealed extremely calcified aorto iliac vessels with calcification extending to the femoral arteries.There were several stents placed in different segments: right common iliac artery, right sfa, and left common iliac artery originating at its ostium.The procedural images show the deployment of the referenced 6 mm x 80 mm eluvia stent in an extremely calcified left external iliac artery.Of note, this location is outside the indications for use of the device.Following post-dilatation of the stent with a 6 x 80 mm balloon, extravasation of contrast can be seen immediately distal to the stent, suggesting arterial rupture.Three minutes later, a second angiographic run shows a decrease in the amount of contrast extravasation, although it is still visible.It is not known whether there was any kind of intervention during those three minutes.The extravasation appears not to be resolved in the last set of images available for review.There was no apparent migration of the stent during the procedure, as evidenced by the images and taking bone structures as geographical reference.The media review revealed that an arterial rupture occurred during post-dilatation of the referenced eluvia stent, which was deployed in an extremely calcified left external iliac artery.

Event Description

The patient was enrolled in the (b)(6) study.It was reported that a stent migration occurred which resulted in patient death.On (b)(6) 2018, the patient was noted to have bilateral claudication.On (b)(6) 2018, duplex ultrasound revealed recurrent stenosis in the right proximal superficial femoral artery (sfa) and external iliac artery.The stenosis in the right sfa was treated with pre-dilatation.After pre-dilatation, a dissection was noted.The dissection was then treated using a 6mm x 80mm eluvia stent.The lesion was then post-dilated with a 5mm x 80mm balloon without residual stenosis.Spasm was noted in the sfa and was treated with continued percutaneous transluminal angioplasty (pta).The restenosis in the left external iliac artery was then treated with a 6mm x 80mm eluvia stent.Post treatment, the lesion was post-dilated with a 5mm x 80mm balloon.During the procedure, post endovascular intervention, a drop in hemoglobin and bloated abdomen was noted and bleeding was suspected from the retroperitoneum.The patient's pressured dropped and had ecg changes, so exploration via the left side of the groin puncture was performed and evaluation revealed the eluvia stent placed in the left external iliac artery had migrated, and massive blood loss was noted due to the migration of the stent, and the stent perforating the external iliac artery.The stent was extracted through open surgery and the external iliac artery was closed.A blood transfusion was also performed.The patient was transferred to the intensive care unit (icu).Despite extensive resuscitation and recovery of blood vessel, the patient died at the icu.The primary cause of death is bleeding from the external iliac artery, perforated by the stent.It was additionally reported that the vessel was minimally tortuous with no calcification.It was also reported that the stent migrated distally and perforated the anterior wall of the artery.

• Brand Name: ELUVIATM DRUG-ELUTING VASCULAR STENT SYSTEM
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8085122
• MDR Text Key: 127593260
• Report Number: 2134265-2018-62633
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P180011
• 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,Followup,Followup
• Report Date: 01/29/2019

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/14/2018
• Initial Date FDA Received: 11/19/2018
• Supplement Dates Manufacturer Received: 01/04/2019; 01/17/2019
• Supplement Dates FDA Received: 01/10/2019; 01/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 53 YR