ELUVIATM DRUG-ELUTING VASCULAR STENT SYSTEM

Report

Report Number: 2134265-2018-62633
Event Type: Death
Date Received: November 19, 2018
Date of Event: July 31, 2018
Report Date: January 29, 2019
Manufacturer: BOSTON SCIENTIFIC CORPORATION
Product Code: NIU
PMA / PMN Number: P180011
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: BE
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

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.

Additional Manufacturer Narrative · 1

DEVICE IS A COMBINATION PRODUCT.

Description of Event or Problem · 1

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.

Description of Event or Problem · 1

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.

Description of Event or Problem · 1

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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
926399	ELUVIATM DRUG-ELUTING VASCULAR STENT SYSTEM	STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING	NIU	BOSTON SCIENTIFIC CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	53 YR		Death