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

Model Number	H74939293062030
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that deployment difficulty occurred.The target lesion was located in the patient¿s left leg.A 6x200x130mm innova¿ stent was advanced to the target lesion and deployment was initiated via rotation of the thumb wheel, however the thumb wheel stopped after 70% of the stent was deployed.The white arrow on the handle was also ¿stuck¿ as it did not allow the physician to deploy the other 30% of the stent.It was reported that the stent eventually deployed, however the physician decided to remove the stent from the patient with no complications.The procedure was not completed due to this event and the patient¿s status was fine post procedure.The patient is scheduled to return to the facility on a later date for treatment.
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of an innova self-expanding stent delivery system (sds) stuck inside a introducer sheath.The outer shaft, middle shaft, inner shaft and the remainder of the device were checked for damage.Visual inspection showed the outer sheath was kinked and buckled at the nose cone.The middle shaft showed no damage of what could be viewed because of the device being stuck inside of the introducer sheath.Part of the stent was deployed inside of the introducer sheath and part of the stent was still in the mid-shaft which may have caused the introducer sheath to be stuck on the catheter shaft.The pull handle was loose inside of the handle which indicates internal damage.The device was opened at the handle.It was noticed that the mid-shaft was pulled from the retainer clip.Quality and research engineering also removed the stent from the introducer sheath to ensure that all of the stent was returned.After measurements were taken it was confirmed that all of the stent was returned.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 is operational context as device performance was limited due to anatomical/procedural factors.(b)(4).
Event or Problem Description
It was reported that deployment difficulty occurred.The target lesion was located in the patient¿s left leg.A 6x200x130mm innova¿ stent was advanced to the target lesion and deployment was initiated via rotation of the thumb wheel, however the thumb wheel stopped after 70% of the stent was deployed.The white arrow on the handle was also ¿stuck¿ as it did not allow the physician to deploy the other 30% of the stent.It was reported that the stent eventually deployed, however the physician decided to remove the stent from the patient with no complications.The procedure was not completed due to this event and the patient¿s status was fine post procedure.The patient is scheduled to return to the facility on a later date for treatment.

• 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: 6497961
• Report Number: 2134265-2017-03576
• Device Sequence Number: 1010599
• Product Code: NIP
• UDI-Device Identifier: 08714729874065
• UDI-Public: (01)08714729874065(17)20191231(10)20109863
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 03/24/2017

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: 12/31/2019
• Device Model Number: H74939293062030
• Device Catalogue Number: 39293-06203
• Device Lot Number: 20109863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/24/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/17/2017
• Supplement Report FDA Received Date: 05/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1