MAUDE Adverse Event Report: MEDTRONIC IRELAND COMPLETE SE SFA; STENT, SUPERFICIAL FEMORAL ARTERY

Device Problems Difficult to Remove (1528); Material Deformation (2976)

Event Date 11/13/2014

Event Type  malfunction  

Event Description

A complete se peripheral stent was being used to treat a severely calcified popiteal and sfa lesion.The stent was successfully deployed.During removal of the delivery system, the tip got caught on the radiopaque marker and/or stent strut causing the stent to become deformed.Additional ballooning was required.Resistance was encountered when advancing the device but excessive force was not used.Device was removed from packaging per ifu.Device was inspected prior to use with no issues noted.Device was prepped per ifu.There was no patient injury reported.

Manufacturer Narrative

(b)(4).Evaluation, results: patients condition affected effectiveness of device (severely calcified lesion); no results available since no evaluation performed; none (device/cines not returned for evaluation).Conclusion, results: device failure/lack of effectiveness related to patient condition (severely calcified lesion); unable to confirm complaint (device/cine not returned).

• Brand Name: COMPLETE SE SFA
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 4318517
• MDR Text Key: 5254545
• Report Number: 9612164-2014-01643
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2014
• Initial Date FDA Received: 12/10/2014
• 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