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

Model Number H74939293071030

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/12/2015

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).Device is a combination product.(b)(4).Device evaluated by mfr.: the device was not returned for evaluation.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 stent migration occurred.The 90% stenosed, 7mm target lesions were located in the right common and right external iliac arteries.A 7 x 100 x 130 innova stent was selected for use, advanced and deployed to treat the lesion.However, post stent deployment, the stent jumped into the aorta.The physician then deployed the balloon proximal to the stent and dragged the innova⠓tent downward to the location where the stent was intended to be implanted.A balloon expandable stent was advanced to the proximal portion of the migrated innova stent, secured the innova stent to the vessel wall and completed the procedure.No patient complications were reported and the patient's status was fine.

• 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: 5274445
• MDR Text Key: 32933865
• Report Number: 2134265-2015-08299
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Model Number: H74939293071030
• Device Catalogue Number: 39293-07103
• Device Lot Number: 18137886
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2015
• 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