MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ELUVIATM 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 Problem Obstruction/Occlusion (2422)

Event Date 02/25/2022

Event Type  Injury  

Event Description

It was reported that an occlusion occurred.Vascular access was obtained via ipsilateral advancing puncture.The target lesion was located in the occluded left superficial femoral artery (sfa).A 6x40, 130cm eluvia drug-eluting vascular stent system was implanted in the mid sfa two years prior.The lesion was approached with a 11cm non-boston scientific sheath, a non-boston scientific guidewire and a non-boston scientific microcatheter.As the lesion was stiffed, the opticross 18 device was switched to a different non-boston scientific guidewire and attempted to crossed through; the lesion was then confirmed using the device without any problem.The guidewire was then switched to a different non-boston scientific guidewire, and a coyote mr 4mm-150mm was used to pre-dilate the lesion and the plaque part before and after stenting.The opticross 18 device was then reinserted to confirm the need for treatment of the lesions before and after stenting, except for those in the stent; however, lost image has occurred during delivery.The opticross device was then removed and the procedure was completed with another of the same.There were no adverse patient effects observed.The procedure was successfully completed by treating the lesion part in the stent with peripheral cutting balloon (pcb).

Manufacturer Narrative

Implant date: two years prior to (b)(6) 2022.

• 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: 13943734
• MDR Text Key: 288172678
• Report Number: 2134265-2022-03558
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• 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: 03/02/2022
• 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
• Treatment: GUIDEWIRE: JUPITER FC, FC3; INTRODUCER SHEATH: SUPERSHEATH 11CM (MEDIKIT); MICROCATHETER: ARMET
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male