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

Model Number 24653

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

Patient Problems Hematoma (1884); Pain (1994); Shock (2072); Ruptured Aneurysm (4436)

Event Date 05/24/2022

Event Type  Injury  

Event Description

It was reported via journal article that an aneurysm formed and then later ruptured post index procedure.The chronic total occlusion (cto) of the right superficial femoral artery (sfa) of a patient with rutherford class-4 symptom was successfully treated with subintimal wire tracking and subsequent implantation of a 7x120mm eluvia drug-eluting vascular stent.Because of iodine-anaphylaxis history, this procedure was guided by co2 angiography and intravascular ultrasound (ivus) for bail out of no-flow phenomenon after first drug-eluting stent (des) implantation.The post-hoc analysis of co2 angiography revealed a small aneurysm in the proximal sfa stented site, but it could not be specified at this time.Six months later, the patient presented with sudden right inguinal pain and hemorrhagic shock with a hemoglobin of 5.1 g/dl.Duplex ultrasound and computed tomography suggested an aneurysm rupture around the stent with a large hematoma extending to the retroperitoneum.Endovascular treatment was performed to minimize any delay until hemostasis was achieved.Co2 angiography and ivus confirmed bleeding outside the stent.Hemostasis was achieved by implanting a 7x100mm non-boston scientific stent-graft inside the initial stent.

Manufacturer Narrative

Date of event estimated using the date the journal article was received for publication.Saito, s., kogame, n., utsunomiya, m.Et al.Delayed rupture of superficial femoral arterial aneurysm at the fluoropolymer-based paclitaxel-eluting stent implanted site.Cardiovasc interv and ther 38, 132-133 (2023).Https://doi.Org/10.1007/s12928-022-00882-y.

• Brand Name: ELUVIA 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16618988
• MDR Text Key: 312038960
• Report Number: 2124215-2023-13855
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female