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

Model Number	26924
Medical Device Problem Codes	Premature Activation (1484); Failure to Advance (2524)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	04/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at the time of event: 18 years or older.Returned product consisted of an innova self-expanding stent system.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the handle is open, the device was returned in several pieces.There are kinks to the inner liner 3.5cm and 5.6cm from the tip.There is a kink to the middle sheath at the distal end of the retainer.Microscopic examination revealed buckling to the middle sheath 3mm, 6mm, and 4.7cm from the distal end of the middle sheath.The stent was deployed and did not return with the device.There is blood on the retainer and in the middle sheath.Inspection of the remainder of the device presented no other damage or irregularities.There was no evidence of any damage or irregularities contributing to the reported crossing difficulty, which could not be confirmed because the clinical circumstances could not be replicated.Product analysis found damages that can potentially cause the device to inadvertently deploy.
Event or Problem Description
It was reported that premature stent deployment occurred.A 5x40x130 innova stent was selected for a percutaneous transluminal angioplasty (pta) procedure in the heavily calcified superficial femoral artery (sfa).The innova stent was unable to cross the lesion.The physician was removing the device from the patient when the stent began to deploy.The physician ended up pulling the stent back to the common femoral artery and deploying the stent in this location.The patient will require bypass surgery to remove the stent as well as to bypass the heavily calcified area.The patient is in fine condition.

• Brand Name: INNOVA VASCULAR
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8638569
• Report Number: 2134265-2019-05732
• Device Sequence Number: 1875604
• Product Code: NIP
• UDI-Device Identifier: 08714729873907
• UDI-Public: 08714729873907
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/12/2021
• Device Model Number: 26924
• Device Catalogue Number: 26924
• Device Lot Number: 0022241971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 05/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention