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

Model Number	26924
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent inadvertently partially deployed.An 8 x 40 x 130 innova was selected for a procedure in the right external iliac.The device was pulled out of the hoop for preparation and it appeared to have already been partially deployed.The device did not enter the patient's body.An 8x40x75 stent was used to complete the procedure.There were no patient complications and the patient was fine.
Event or Problem Description
It was reported that the stent inadvertently partially deployed.An 8 x 40 x 130 innova was selected for a procedure in the right external iliac.The device was pulled out of the hoop for preparation and it appeared to have already been partially deployed.The device did not enter the patient's body.An 8x40x75 stent was used to complete the procedure.There were no patient complications and the patient was fine.Returned product consisted of an innova self-expanding stent delivery system (sds).The outer sheath, mid-shaft, and the remainder of the device were checked for damage.Visual examination showed a kink at the nosecone.It was noticed that the stent was partially deployed approximately 9mm from the distal side of the markerband.The yellow thumbwheel lock was intact on the device.The pull handle was at the start position.The cis investigator rotated the thumbwheel to verify functionality of the device.The stent started to deploy as designed with no issues.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

• 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: 7911338
• Report Number: 2134265-2018-61277
• Device Sequence Number: 1722558
• Product Code: NIP
• UDI-Device Identifier: 08714729874171
• UDI-Public: 08714729874171
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2018

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: 11/30/2019
• Device Model Number: 26924
• Device Catalogue Number: 26924
• Device Lot Number: 0019946625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 09/26/2018
• Supplement Report FDA Received Date: 11/01/2018
• Patient Sequence Number: 1