MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE INNOVA¿; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	H74939293072030
Medical Device Problem Codes	Bent (1059); Break (1069); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/28/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
It was reported that the stent partially deployed, the stent elongated, and a portion of the stent detached.A 7 x 200 x 130 innova self-expanding stent was selected for a procedure in the right superficial femoral artery.An antegrade approach was used.When they were deploying the stent, they pulled the pin to release the 200 length stent.However, the last portion of the stent became hung up within the delivery system and would not release.They pulled on it assuming that the stent would release itself.Rather, the stent elongated and a portion of the stent detached.The proximal portion of the stent was detached from the stent itself.They removed the detached piece and stent through the sheath.Nothing was left inside the patient's body.The procedure was completed with a different device.Ballooned angioplasty was performed in the remaining portion and the procedure was completed.There were no patient complications and the patient was fine.

• Brand Name: INNOVA¿
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• MDR Report Key: 6117044
• Report Number: 2134265-2016-10549
• Device Sequence Number: 876441
• Product Code: NIP
• UDI-Device Identifier: 08714729874157
• UDI-Public: (01)08714729874157(17)20180731(10)18240225
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/01/2016

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: 07/31/2018
• Device Model Number: H74939293072030
• Device Catalogue Number: 39293-07203
• Device Lot Number: 18240225
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2016
• Initial Report FDA Received Date: 11/21/2016
• 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