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

Model Number H74939181072030

Device Problems Bent (1059); Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2014

Event Type  Injury  

Event Description

It was reported that during a stenting treatment procedure, stent deformation occurred.Vascular access was obtained via the femoral artery.The eccentric shaped, de novo target lesion was located in the severely calcified, 7mm in diameter superficial femoral artery.This 7x200x130 innova stent delivery system was selected and inserted with the thumbwheel.However, the stent became stuck.The stent was only partially opened and could not have been opened anymore, even after using the thumbwheel and the pullback grip.Then the user ¿giggled¿ the stent and finally deployed the stent.It was noted that there was significant resistance encountered during repositioning and the stent was unable to be deployed smoothly.The stent was also deformed in the middle part of the stent.A 7x150 innova stent was deployed to cover the damaged area.The lesion was post dilated with a 6x80mmx75cm mustang balloon catheter.No patient complications were reported and the patient¿s status is stable.This product is only ous approved, but it is similar to an approved us device.

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).Device evaluated by manufacturer: it is indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

• 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: 4331628
• MDR Text Key: 15354277
• Report Number: 2134265-2014-07844
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/25/2014

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: 01/28/2017
• Device Model Number: H74939181072030
• Device Catalogue Number: 39181-07203
• Device Lot Number: 16698632
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2014
• Initial Date FDA Received: 12/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2014
• 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