MAUDE Adverse Event Report: MEDTRONIC IRELAND INTEGRITY RX; STENT, CORONARY

Catalog Number	INT35012UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician intended to use an integrity rx coronary bare metal stent to treat a severely tortuous and moderately calcified lesion located in the ostium right coronary artery, exhibiting 85% stenosis.There was no damage noted to packaging and no issues noted when removing the device from the hoop/tray.The device was inspected and negative prep was performed with no issues noted.The lesion was pre-dilated.The device did not pass a previously-deployed stent.Resistance was encountered when advancing the device and excessive force was used during delivery.It was reported that the stent failed to cross position; the stent failed to cross the first time.It was reported that the stent would not cross because the guide wasn't the correct size for the anatomy.The doctor changed out the catheter and went to use the stent again.The physician noticed while loading the stent on the wire that either the stent strut was sticking up or there was tissue on the strut.It was reported that it was too small to tell.The physician decided to use another stent instead and it was successfully implanted.The integrity rx stent went into the body once.No dissection or any anatomical damage was noted.Patient status post-procedure is alive with no injury.
Additional Manufacturer Narrative
Product analysis: the stent was positioned on the balloon between the marker bands as per specifications.Strut misalignment was evident to the 1st distal stent wraps.Slight deformation was evident to the distal tip.The inner lumen patency was verified with a 0.015 inch mandrel.The device returned with foreign material present on the struts.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: INTEGRITY RX
• Common Device Name: STENT, CORONARY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7116442
• Report Number: 9612164-2017-01938
• Device Sequence Number: 13777792
• Product Code: MAF
• UDI-Device Identifier: 00613994798558
• UDI-Public: 00613994798558
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P030009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/12/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2019
• Device Catalogue Number: INT35012UX
• Device Lot Number: 0008656609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2017
• Initial Date Received by Manufacturer: 11/27/2017
• Supplement Date Received by Manufacturer: 01/31/2018; 03/26/2018
• Initial Report FDA Received Date: 12/14/2017
• Supplement Report FDA Received Date: 02/28/2018; 04/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1