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

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

Patient Problems Inflammation (1932); Arteriosclerosis/ Atherosclerosis (4437); Restenosis (4576); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/03/2021

Event Type  Injury  

Manufacturer Narrative

Literature reference: tsujimura, t., lida, o., asai, m., masuda, m., okamoto, s., ishihara, t.,.Mano, t.(2021).Aneurysmal degeneration of fluoropolymer-coated pactitaxel-eluting stent in the superficial femoral artery: a rising concern.Cvir endovascular, 1-6.Date of event was approximated using date article was published.

Event Description

Reported via journal article that within this study, it was reported that in-stent restenosis occurred.The journal reports a single case with progressive aneurysm formation on serial angiography and intravascular ultrasound over 50 months after drug-eluting stent (eluvia) placement for a superficial femoral artery (sfa) atheromatous plaque.The patient presented with right leg intermittent claudication.Pre-procedural angiography showed long-segment severe stenosis from the middle-to-distal part of the right sfa, and a 7mmx 150mm wide eluvia drug-eluting stent was placed without pre-dilation as the lesion was not severely calcified.After stent placement, the lesion was post-dilated resulting in optimal expansion.However, the patient had a recurrence of intermittent claudication in the right lower extremity 25 months following the placement.Angiography revealed de novo stenosis in the distal part of the popliteal artery and proximal superficial femoral artery in-stent restenosis.The patient was treated with endovascular therapy with a non-bsc drug coated stent placed for the proximal in-stent restenosis of the eluvia stent.During the endovascular, intravascular ultrasound revealed femoral artery enlargement with a maximum vessel diameter of 10mm at the distal edge of the stent.The patient was symptom-free until intermittent claudication returned again 50 months after the eluvia stent was placed.Angiography demonstrated de novo severe stenosis from the distal part of the sfa to the middle part of the popliteal artery.The popliteal artery and distal sfa were dilated with a drug-coated balloon.Peri-stent contrast staining was found at the distal part of the drug-eluting stent (eluvia) site.Intravascular ultrasound showed a further enlargement of maximum vessel diameter to 12mm at the distal edge of the eluva stent.Enlargement of the lumen and stent malposition were also found, suggesting progressive aneurysmal degeneration 50 months after eluvia placement.Similarly, duplex images showed a hypoechogenic halo suggestive of aneurysmal degeneration around the distal edge of the eluvia.Additionally, several clinical studies reported instances of aneurysmal degeneration 12 or 24 months after drug-eluting stent (eluvia) placement.Another article reported that 5 of 62 patients treated by drug-eluting stent (eluvia) placement had aneurysmal degeneration and one of these presented with clinical worsening caused by the occlusion of the stent.

Event Description

Reported via journal article that within this study, it was reported that in-stent restenosis occurred.The journal reports a single case with progressive aneurysm formation on serial angiography and intravascular ultrasound over 50 months after drug-eluting stent (eluvia) placement for a superficial femoral artery (sfa) atheromatous plaque.The patient presented with right leg intermittent claudication.Pre-procedural angiography showed long-segment severe stenosis from the middle-to-distal part of the right sfa, and a 7mmx 150mm wide eluvia drug-eluting stent was placed without pre-dilation as the lesion was not severely calcified.After stent placement, the lesion was post-dilated resulting in optimal expansion.However, the patient had a recurrence of intermittent claudication in the right lower extremity 25 months following the placement.Angiography revealed de novo stenosis in the distal part of the popliteal artery and proximal superficial femoral artery in-stent restenosis.The patient was treated with endovascular therapy with a non-bsc drug coated stent placed for the proximal in-stent restenosis of the eluvia stent.During the endovascular, intravascular ultrasound revealed femoral artery enlargement with a maximum vessel diameter of 10mm at the distal edge of the stent.The patient was symptom-free until intermittent claudication returned again 50 months after the eluvia stent was placed.Angiography demonstrated de novo severe stenosis from the distal part of the sfa to the middle part of the popliteal artery.The popliteal artery and distal sfa were dilated with a drug-coated balloon.Peri-stent constrast staining was found at the distal part of the drug-eluting stent (eluvia) site.Intravascular ultrasound showed a further enlargement of maxiumum vessel diameter to 12mm at the distal edge of the eluva stent.Englargement of the lumen and stent malapposition were also found, suggesting progessive aneurysmal degeneration 50 months after eluvia placement.Similarly, duplex images showed a hypoechogenic halo suggestive of aneurysmal degeneration around the distal edge of the eluvia.Additionally, several clinical studies reported instances of aneurysmal degeneration 12 or 24 months after drug-eluting stent (eluvia) placement.Another article reported that 5 of 62 patients treated by drug-eluting stent (eluvia) placement had aneurysmal degeneration and one of these presented with clinical worsening caused by the occlusion of the stent.

Manufacturer Narrative

Corrections: h6 patient codes and impact codes.Literature reference: tsujimura, t., lida, o., asai, m., masuda, m., okamoto, s., ishihara, t.,.Mano, t.(2021).Aneurysmal degeneration of fluoropolymer-coated pactitaxel-eluting stent in the superficial femoral artery: a rising concern.Cvir endovascular, 1-6.B3: date of event was approximated using date article was published.

• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12729085
• MDR Text Key: 279325198
• Report Number: 2134265-2021-13592
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• 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?: No
• Date Manufacturer Received: 12/15/2021
• 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): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female