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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Occlusion (1984)

Event Date 12/01/2014

Event Type  Injury  

Event Description

During index procedure a complete se peripheral stent was used to treat a lesion located in the sfa of the right leg.Approximately 12 months later it is reported that the patient suffered from restenosis of the r.Sfa.Investigator indicated the event was not related to the device or procedure.Event is continuing.Approximately 18 months post the index procedure it is reported that the patient suffered from re-occlusion of the r.Sfa.Event is continuing.

Manufacturer Narrative

(b)(4).Evaluation results: inherent risk of procedure (occlusion of sfa artery or distal vasculature).Evaluation conclusion: known inherent risk of procedure (occlusion of sfa artery or distal vasculature).

Event Description

Approximately 19 months post index procedure a revascularization of the right sfa was performed to treat the previously reported right sfa re-occlusion event approximately 18 months post index procedure.2 non medtronic balloons, 2 pacific plus balloons, one in.Pact pacific balloon and a non medtronic stent were used as treatment.

Manufacturer Narrative

Evaluation, results - inherent risk of procedure (occlusion/restenosis).

• 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: 4299354
• MDR Text Key: 5058722
• Report Number: 9612164-2014-01599
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P110040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/08/2014

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2014
• Initial Date FDA Received: 12/05/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/18/2014
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 00067 YR
• Patient Weight: 99