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

Model Number	H74939293052030
Medical Device Problem Codes	Fracture (1260); Stretched (1601); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the stent partially deployed, fractured, and elongated.A 5 x 200 x 130 innova¿ stent was selected for a procedure in the superficial femoral artery.Deployment of the device was initiated over the 0.035 non-bsc guidewire.After approximately 75% of the stent was deployed, the device would no longer deploy.The pull grip was attempted to be used but did not work.The stent fractured at the last quarter and the last quarter remained within the delivery system.The two stent portions were removed.The deployed portion of the stent was removed by snaring the corner of the strut and pulling the device out through the sheath.It appeared as if the stent was elongated.The procedure was completed with three other smaller stents.There were no patient complications and the patient was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.:returned product consisted of an innova self-expanding stent delivery system (sds).The outer shaft, mid-shaft and the remainder of the device were checked for damage.Visual examination showed a kink at the nosecone.The outer sheath showed bunching at 63.5cm from the markerband.The mid-shaft showed damage in the form of a kink.The kink was located approximately 3.5cm from the markerband.The stent was returned and fractured.The pull handle was loose in the handle which is an indication of the mid-shaft pulling out from the retainer clip.The handle was separated to visually inspect inside for further damage.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 further reported that this event was reported via user facility medwatch # (b)(4).Manufacturer mdr id 2134265-2017-07723 is a duplicate of this event.

• 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: 6732529
• Report Number: 2134265-2017-07220
• Device Sequence Number: 19122953
• Product Code: NIP
• UDI-Device Identifier: 08714729873976
• UDI-Public: (01)08714729873976(17)20190630(10)0019367647
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2017

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: 06/30/2019
• Device Model Number: H74939293052030
• Device Catalogue Number: 39293-05203
• Device Lot Number: 0019367647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2017
• Initial Date Received by Manufacturer: 06/30/2017
• Supplement Date Received by Manufacturer: 07/27/2017
• Initial Report FDA Received Date: 07/21/2017
• Supplement Report FDA Received Date: 08/18/2017
• 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