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

Model Number H74939180072070

Device Problems Detachment Of Device Component (1104); Activation, Positioning or Separation Problem (2906); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/11/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that deployment issues, stent dislodgement and tip detachment occurred.The target lesion was located in the superficial femoral artery.Following the insertion of a 0.018 non-bsc guide wire and 6f non-bsc guide sheath, a 7x200x75 innova¿ stent was advanced to treat the lesion.Deployment was started and when around 5cm of the stent was deployed, the thumbwheel could no longer move.The physician then attempted to release the stent with the pull grip, but the grip was also locked.When the physician attempted to remove the delivery system, the stent dislocated to the proximal femoral artery.Subsequently, the physician removed the sheath with the delivery system, which lead to an elongation of the stent over the aortic bifurcation and loss of the tip of the delivery system.With kissing stents, the physician covered the detached tip and the biggest part of the stent.One part of the stent is still not covered and was removed through surgery.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by manufacturer: returned product consisted of portion of the innova stent delivery system with a.018¿ guidewire in the lumen.The guidewire was protruding 27.5cm from the distal end of the shaft and 60cm from the end of the handle.There was blood on the handle and in the shaft.The tip and inner liner (shaft) were detached/separated and not returned.The shaft was kinked at the nose cone.The x-ray showed that the guidewire was deformed within the handle rack slot.Upon opening the handle, the proximal inner (shaft) was verified to be damaged but within rack slot.The damage was noted to be adjacent to the rack o-ring.The damaged proximal inner would not pass through o-ring, essentially locking the system up with the 0.018¿ guidewire.The damage to the proximal inner is consistent with using excessive force.The stent was not received for analysis.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 Description

It was reported that deployment issues, stent dislodgement and tip detachment occurred.The target lesion was located in the superficial femoral artery.Following the insertion of a 0.018 non-bsc guide wire and 6f non-bsc guide sheath, a 7x200x75 innova stent was advanced to treat the lesion.Deployment was started and when around 5cm of the stent was deployed, the thumbwheel could no longer move.The physician then attempted to release the stent with the pull grip, but the grip was also locked.When the physician attempted to remove the delivery system, the stent dislocated to the proximal femoral artery.Subsequently, the physician removed the sheath with the delivery system, which lead to an elongation of the stent over the aortic bifurcation and loss of the tip of the delivery system.With kissing stents, the physician covered the detached tip and the biggest part of the stent.One part of the stent is still not covered and was removed through surgery.No patient complications were reported and the patient's status was stable.

• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5490049
• MDR Text Key: 40016349
• Report Number: 2134265-2016-01468
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/11/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: H74939180072070
• Device Catalogue Number: 39180-07207
• Device Lot Number: 18751463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/2016
• Initial Date FDA Received: 03/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2016
• 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
• Patient Age: 67 YR