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

Model Number	26926
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/22/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent partial deployment occurred.The greater than 50% stenosed target lesion was located in the normally tortuous and highly calcified left lower extremity.Following pre-dilation, a 5 x 150 x 130 innova stent was advanced ipsilateral over a non-bsc guidewire and stent deployment was initiated.The thumbwheel was used to deploy the stent.The thumbwheel was able to deploy 95% of the stent.The pull grip was attempted to deploy the remaining 5% but the pull grip did not work.The physician then backed the delivery catheter over the wire and the stent released and was able to deploy.The stent did not appear stretched or elongated.The stent was deployed in the target lesion.The percutaneous transluminal angioplasty (pta) procedure was completed.There were no patient complications and the patient was fine.

• 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: 8430520
• Report Number: 2134265-2019-02383
• Device Sequence Number: 240596
• Product Code: NIP
• UDI-Device Identifier: 08714729873952
• UDI-Public: 08714729873952
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/21/2020
• Device Model Number: 26926
• Device Catalogue Number: 26926
• Device Lot Number: 21410654
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2019
• Initial Report FDA Received Date: 03/18/2019
• Patient Sequence Number: 1
• Patient Age: 83 YR