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

Model Number	26926
Medical Device Problem Codes	Fracture (1260); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of birth: patient was born in (b)(6).
Event or Problem Description
It was reported that the stent partially deployed and 1/3 of the stent was left in the patient.A 5x150x130 innova vascular stent was selected for a lower extremity runoff procedure in the patient's totally occluded superficial femoral artery (sfa).The lesion was of normal tortuosity and heavily calcified.The lesion was approached contralaterally and was pre-dilated.The device was used with an unspecified amplatz guidewire and a non-bsc sheath.While attempting to deploy, the thumbwheel only worked for the first 1/3 of the delivery of the stent and then stopped deploying the stent.Normal force was required to turn the thumbwheel.The pull grip was attempted to be used to deploy the stent, but still only approximately 1/3 of the stent deployed in the sfa.The physician broke the stent to remove the whole system, but left the 1/3 of the stent inside of the patient's subintimal plane.The rest of the stent, that was remaining in the sheath, was removed from the patient.The case was finished at that point.No portion of the fractured stent was sticking out of the subintimal plane to obstruct blood flow.The physician chose not to remove the fractured portion because it was in the subintimal plane.The physician has no concerns at this point.The patient will be going for surgical bypass at an undisclosed time.In the physician's opinion the patient did not go to surgery due to the issue with this device, but because the case was unsuccessful to stent.The patient was fine.There were no patient complications or symptoms and no actions were taken due to this issue.

• 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: 8445254
• Report Number: 2134265-2019-02844
• Device Sequence Number: 14013753
• Product Code: NIP
• UDI-Device Identifier: 08714729873952
• UDI-Public: 08714729873952
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/22/2019

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: 04/05/2021
• Device Model Number: 26926
• Device Catalogue Number: 26926
• Device Lot Number: 0021955574
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 03/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TERUMO 6FR DESTINATION SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR