MAUDE Adverse Event Report: MEDTRONIC IRELAND ASSURANT COBALT; STENT, ILIAC

Model Number PXP35-10-27-080

Device Problems Therapy Delivered to Incorrect Body Area (1508); Activation, Positioning or Separation Problem (2906); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The physician intended to use the visipro stent to treat the common iliac artery as per ifu.It was reported the stent slid off the balloon whilst advancing through the sheath.Another device was used to complete the procedure.No patient injury reported.

Manufacturer Narrative

Additional information received.It was initially reported that a visipro stent was used during the index.An assurant cobalt was received for evaluation.Confirmation was received that the assurant cobalt was the device used during the index procedure.Device evaluation: the stent was not present on the balloon and did not return for analysis.Crimp impressions were visible on the exposed balloon surface.The proximal balloon folds were kinked.The proximal balloon folds were cut away to exposed the inner shaft.The inner shaft was kinked and pinched approx.1cm distal to the proximal balloon bond.(b)(4).

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ASSURANT COBALT
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway MN
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway MN
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6184784
• MDR Text Key: 62673638
• Report Number: 2183870-2016-00724
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P110011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Health Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2018
• Device Model Number: PXP35-10-27-080
• Device Catalogue Number: ASC1030L
• Device Lot Number: 0008169849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2016
• 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