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

Model Number H74939181061830

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Event Description

It was reported that stent migration occurred.The target lesion was located in the superficial femoral artery (sfa).A 6x180x130 innova¿ stent was implanted to treat the lesion.However, the stent migrated distally and the lesion was not fully covered.No additional intervention was done to correct this event.The procedure was completed with no further patient complications reported and the patient's status was good.

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the device was not returned for analysis.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).

• 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: 4952530
• MDR Text Key: 6639192
• Report Number: 2134265-2015-04852
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: KR
• 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: 07/03/2015

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: 08/17/2017
• Device Model Number: H74939181061830
• Device Catalogue Number: 39181-06183
• Device Lot Number: 17205983
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/03/2015
• Initial Date FDA Received: 07/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other