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

Model Number	26928
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/23/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent inadvertently began to deploy.A 6x100x130 innova self-expanding stent was selected to be implanted in the lower extremity of the patient.The physician had previously implanted two other stents.As the device was in the process of entering the sheath outside the patient, it began to prematurely deploy before the safety lock had been removed.The stent did not fully deploy.A different device, which was the same model, was used to complete the procedure.The patient experienced no adverse effects and was fine.
Event or Problem Description
It was reported that the stent inadvertently began to deploy.A 6x100x130 innova self-expanding stent was selected to be implanted in the lower extremity of the patient.The physician had previously implanted two other stents.As the device was in the process of entering the sheath outside the patient, it began to prematurely deploy before the safety lock had been removed.The stent did not fully deploy.A different device, which was the same model, was used to complete the procedure.The patient experienced no adverse effects and was fine.
Additional Manufacturer Narrative
Device analysis by mfr: the returned product consisted of an innova self-expanding stent system.Visual examination revealed that the stent is partially deployed approximately 4.7mm from the distal end of the middle sheath.The stent is stretched/deformed.Microscopic examination revealed scratch marks around the tip of the device.The lock and rack are still in the manufactured position.Inspection of the remainder of the device, 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: 9316555
• Report Number: 2134265-2019-13728
• Device Sequence Number: 2373944
• Product Code: NIP
• UDI-Device Identifier: 08714729874027
• UDI-Public: 08714729874027
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 11/20/2019

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: 09/04/2020
• Device Model Number: 26928
• Device Catalogue Number: 26928
• Device Lot Number: 0021093003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Initial Date Received by Manufacturer: 10/23/2019
• Supplement Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 11/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1