MAUDE Adverse Event Report: MEDTRONIC IRELAND COMPLETE SE ILIAC; STENT, ILIAC

Catalog Number SC6120LG

Device Problems Occlusion Within Device (1423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Loss Of Pulse (2562); Alteration In Body Temperature (2682)

Event Date 06/16/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The physician used a complete se device to treat a lesion in the left sfa which exhibited 75% stenosis, severe calcification and slight vessel tortuosity.No abnormality was noted in the device inspection before use.Lesion pre-dilation was not performed.It was reported that during implantation of the complete se stent, the stent appeared to be severely shortened.After implantation the length was 60 mm.It was indicated that there was friction with the guidewire or guide catheter during the procedure.Post-dilation was not performed.The physician then implanted another 2 complete se devices of the same size.The stents deployed normally however it was reported that the physician found no blood flow in the stents.It was reported that it was possible the blood flow problem was due to the stent being implanted in the subintimal.The physician dilated the entrance and the blood flow was normal.The patient was hospitalized for 2 weeks.Approximately 4 weeks post procedure the patient was reported to have suffered from skin temperature decrease and no pulse was felt below the knee by touch.The patient was transferred to another hospital for treatment.

• Brand Name: COMPLETE SE ILIAC
• Type of Device: STENT, ILIAC
• 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: 4999050
• MDR Text Key: 22820924
• Report Number: 9612164-2015-01388
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P090006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 07/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SC6120LG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 00074 YR