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 Thrombosis (2100); Ulcer (2274); No Code Available (3191)

Event Date 04/27/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that in-stent thrombosis occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery (sfa).Three eluvia stents, 6 mm x 120 mm, 7 mm x 120 mm, and 7 mm x 120 mm, were implanted in the sfa on (b)(6) 2019.The procedure was successful.On (b)(6) 2020, one month prior to confirmation of stent occlusion (3 months after endovascular thrombectomy (evt)), no stenosis was observed.Mild stenosis was confirmed in the partial stent expansion failure.Subsequently, it was judged as stent thrombosis due to occlusion.The stent was occluded in the middle 2/3 part and in the distal 1/3 part, however no occlusion was confirmed in collateral flow.The patient had symptoms that consisted of lameness and a toe ulcer that was improved after the first treatment, but still unhealed.On (b)(6) 2020, follow-up revealed the ankle brachial index dropped to 0.3 and stent occlusion was revealed.Angiography confirmed the mid part of an unspecified eluvia stent was not fully expanded.Evt was discontinued and a femoral popliteal (fp) bypass of the right common femoral artery (cfa) to the p2 popliteal artery (pop) with autologous vein grout was performed.The physician noted that the lesion was successfully dilated with a high pressure resistant balloon during the procedure, but it was thought the stent might have been flattened due to the recoil of the severely calcified lesion.There were no patient complications reported.The patient condition after treatment was fine, and symptoms disappeared.The ulcer was unhealed but was improved.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10259742
• MDR Text Key: 198413135
• Report Number: 2134265-2020-09148
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2021
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0023436394
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2019
• 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
• Treatment: BEASTOR BOSTON
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR