MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INNOVA VASCULAR; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number 26924

Device Problems Material Integrity Problem (2978); Activation Problem (4042)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2019

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.

Event Description

It was reported that stent damage occurred.A 6x40x130 innova vascular stent was selected for a percutaneous transluminal angioplasty procedure.The severely calcified, moderately tortuous, 99% stenosed lesion was accessed by ipsilateral approach.After the unspecified guidewire was passed through, and the stent delivery system was delivered to the target lesion, the physician tried to perform stenting with this device, but the thumbwheel would not move/activate while attempting to deploy the stent, so the device was removed.When checking the device after removal, the distal tip of the stent struts were found to be flared and lifted up.Therefore the device was replaced with an eluvia stent to complete the stenting.The same unspecified guidewire was used to complete the procedure.No patient complications were reported.

• Brand Name: INNOVA VASCULAR
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8449848
• MDR Text Key: 139805072
• Report Number: 2134265-2019-01896
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08714729873990
• UDI-Public: 08714729873990
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P140028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/08/2020
• Device Model Number: 26924
• Device Catalogue Number: 26924
• Device Lot Number: 0021231180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2017
• 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