MAUDE Adverse Event Report: MEDTRONIC IRELAND RESOLUTE INTEGRITY RX; STENT, CORONARY, DRUG-ELUTING

Model Number RSINT25018UX

Device Problems Difficult To Position (1467); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the physician was attempting to use a resolute integrity rx drug eluting stent.Lesion was calcific.No issues were noted when removing the device from the hoop/tray.The device was inspected and negative prep performed with no issues noted.During the procedure, it was reported that stent deformation in vivo during positioning occurred.Physician attempted to cross the lesion several times without success.On removal, damage was noted to the device.There was a tear in the side of the stent and struts were sticking out.The physician completed the procedure.No patient injury reported.

Manufacturer Narrative

Additional information received: the device was used to treat a moderately calcified and tortuous mid lad lesion.No damage was noted to the device packaging.The lesion was pre-dilated.During the procedure, the stent did pass through a previously deployed stent.Resistance was noted when advancing the stent and excessive force used.The stent caught on a previously implanted stent and pulled the strut out.The stent was replaced with a smaller resolute.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Device evaluation: kinks were visible on the hypotube and distal shaft of the returned device.The stent was positioned on the balloon between the marker bands as per specifications.Deformation was visible to the 4th, 5th, 6th and 7th distal stent wraps with raised a bunched struts.Crimp impressions were visible on the exposed balloon surface.The most proximal stent wrap was slightly expanded.There was damage to the distal tip.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE INTEGRITY RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• 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: 5924447
• MDR Text Key: 53803465
• Report Number: 9612164-2016-00933
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/13/2017

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
• Device Expiration Date: 10/05/2017
• Device Model Number: RSINT25018UX
• Device Catalogue Number: RSINT25018UX
• Device Lot Number: 0007774683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2016
• Initial Date FDA Received: 09/02/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/14/2017; 06/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2015
• 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