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

Catalog Number	INT30015UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An attempt was made to use one integrity rx coronary bare metal stent to treat a very calcified lesion located in the distal circumflex (cx) artery.Negative prep was performed.The hoop was not flushed.It was reported that the stent was unable to cross the very calcified lesion and was removed from the patient.It was observed on removal of the stent from the patient that one of the struts was raised up.The procedure was completed by pre-dilating with a 2.5x15mm balloon and implanting another 3.0x15mm stent.No patient injury is reported.
Additional Manufacturer Narrative
The device was inspected prior to use with no issues reported.The lesion was pre-dilated with a 2.5x15mm euphora balloon.No resistance was noted while the stent traversed the guide catheter.However, resistance was encountered at the lesion.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: 8119332
• Report Number: 9612164-2018-03431
• Device Sequence Number: 18889344
• Product Code: MAF
• UDI-Device Identifier: 00613994798497
• UDI-Public: 00613994798497
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 03/07/2019

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: 06/12/2020
• Device Catalogue Number: INT30015UX
• Device Lot Number: 0009184186
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/20/2018
• Supplement Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 11/30/2018
• Supplement Report FDA Received Date: 03/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1