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

Model Number	H74939293072030
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned product consisted of an innova self-expanding stent delivery system (sds) with an introducer sheath.The outer shaft and the remainder of the device were checked for damage.The device was returned with the handle opened.Visual examination showed a kink at the nosecone.The mid-shaft showed a kink approximately 53.5cm from the markerband.The mid-shaft also showed damage at the markerband.The mid-shaft was detached from the retainer clip.The stent was returned stuck inside of the introducer sheath.The proximal inner was kinked approximately 1.5cm from the retainer clip.The inner liner and the tip was separated and stuck inside of the introducer sheath.The mid-shaft was pulled from the outer sheath to determine the failure of the mid-shaft separation from the retainer clip.It was noticed that the mid-shaft had separated from the retainer clip, the mid-shaft substrate had failed.The retainer clip was then removed from the pull rack to view inside and validate the separation.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).
Event or Problem Description
It was reported that the stent failed to deploy properly.A 7 x 200 x 130 innova¿ stent was selected for a procedure.During the procedure, while inside the patient, the stent failed to deploy properly and the mechanism failed.There was no harm to the patient.

• 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: 7008615
• Report Number: 2134265-2017-10715
• Device Sequence Number: 18956920
• Product Code: NIP
• UDI-Device Identifier: 08714729874157
• UDI-Public: 08714729874157
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 10/12/2017

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: 03/31/2020
• Device Model Number: H74939293072030
• Device Catalogue Number: 39293-07203
• Device Lot Number: 20352590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2017
• Initial Report FDA Received Date: 11/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 92169170-FA
• Patient Sequence Number: 1