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

Model Number H74939293061830

Device Problems Detachment Of Device Component (1104); Stretched (1601); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the shaft detached, the stent partially deployed, and the stent became damaged.The 100% stenosed, severely calcified, and severely tortuous target lesion was located in the left superficial femoral artery (sfa).A 6 x 180 x 130 innova¿ stent was selected for use.Over a period of several hours, a 0.014 guidewire was crossed to the lesion area and poba was performed.After poba, the physician changed to a 0.035 guidewire in order to deliver the stent, but the 0.035 guidewire was unable to cross the lesion area.So, the 0.014 guidewire was crossed to the lesion again and poba was performed.After that, delivery using the 0.035 guidewire was discontinued and this stent was delivered to the lesion area along with the 0.014 guidewire.High force was required to turn the thumbwheel.After 5-7 cm of delivery, an abnormal sound was heard during deployment from inside the thumbwheel and the stent was unable to further deploy with the thumbwheel.The pull grip was the only way to expand the stent.The silver outer sheath of the shaft was found to be detached.The stent was forcibly placed inside the patient¿s body by directly pulling out the system.The stent became stretched about 10-12 cm elongating from 18cm to about 30cm.Repair was attempted by performing apposition using a balloon.Poba was performed but apposition was unable to be performed.The procedure was completed with the vasculature totally occluded.There were no additional patient complications.

Manufacturer Narrative

Device evaluated by mfr.:returned product consisted of an innova self-expanding stent delivery system (sds) and no other devices.The outer sheath, middle shaft, inner liner and the remainder of the device were examined for damage.The outer sheath showed multiple kinks and buckling.The mid-shaft, proximal inner and the inner liner were completely separated from the device when returned.A kink was noticed on the mid-shaft approximately 69cm from the marker band.A kink was noticed on the inner liner at the proximal inner distal end.The handle was opened to inspect for additional damage.It was noticed that the mid-shaft had separated from the retainer clip.The inner liner was also separated from the clip.No additional damage was noticed.The stent was not returned in the device.No damage was noticed inside of the handle.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 cause of the reported difficulties may be due interaction with another device.(b)(4).

Event Description

It was reported that the shaft detached, the stent partially deployed, and the stent became damaged.The 100% stenosed, severely calcified, and severely tortuous target lesion was located in the left superficial femoral artery (sfa).A 6 x 180 x 130 innova¿ stent was selected for use.Over a period of several hours, a 0.014 guidewire was crossed to the lesion area and poba was performed.After poba, the physician changed to a 0.035 guidewire in order to deliver the stent, but the 0.035 guidewire was unable to cross the lesion area.So, the 0.014guidewire was crossed to the lesion again and poba was performed.After that, delivery using the 0.035 guidewire was discontinued and this stent was delivered to the lesion area along with the 0.014 guidewire.High force was required to turn the thumbwheel.After 5-7 cm of delivery, an abnormal sound was heard during deployment from inside the thumbwheel and the stent was unable to further deploy with the thumbwheel.The pull grip was the only way to expand the stent.The silver outer sheath of the shaft was found to be detached.The stent was forcibly placed inside the patient¿s body by directly pulling out the system.The stent became stretched about 10-12 cm elongating from 18cm to about 30cm.Repair was attempted by performing apposition using a balloon.Poba was performed but apposition was unable to be performed.The procedure was completed with the vasculature totally occluded.There were no additional patient complications.

• Brand Name: INNOVA¿
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6660570
• MDR Text Key: 78175958
• Report Number: 2134265-2017-06102
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• PMA/PMN Number: P140028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: H74939293061830
• Device Catalogue Number: 39293-06183
• Device Lot Number: 19589364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention