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

Catalog Number	INT30012UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/17/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The physician intended to use an integrity stent in the mid rca.The lesion was heavily calcified, and mildly tortuous.No abnormalities were reported in relation to anatomy.The lesion was predilated.No issues were noted when the device was inspected before use.Resistance noted when advancing the device.It was reported that this was caused by the calcium.Aggressive force was used.It was reported that stent deformation in-vivo occurred during positioning/advancement.A stent strut flared on the proximal edge.No stent was deployed as none would cross.The patient did not suffer any injuries.
Additional Manufacturer Narrative
Evaluation summary: numerous kinks were evident along the hypotube.The stent was positioned on the balloon between the marker bands as per specifications.Deformation was evident to the 11-12th distal stent wraps with struts raised and bunched.No deformation was evident to the distal tip.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: 7265893
• Report Number: 9612164-2018-00344
• Device Sequence Number: 16578558
• Product Code: MAF
• UDI-Device Identifier: 00613994798480
• UDI-Public: 00613994798480
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 04/17/2018

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: 07/04/2019
• Device Catalogue Number: INT30012UX
• Device Lot Number: 0008700723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Initial Date Received by Manufacturer: 01/19/2018
• Supplement Date Received by Manufacturer: 03/21/2018
• Initial Report FDA Received Date: 02/13/2018
• Supplement Report FDA Received Date: 04/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Weight: 101