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

Catalog Number	INT30018UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: the hypotube was slightly kinked.The stent was positioned on the balloon between the marker bands as per specifications.There was deformation to the 7th distal stent wrap with raised struts.The distal tip was damaged.(b)(4).
Event or Problem Description
The physician was attempting to use an integrity stent to treat a severely tortuous mid lad lesion.It was reported that no damage was noted to the device packaging.No issues were encountered when removing the devices from the hoop/tray.Negative prep was not performed.The device was inspected with no issues noted.The device did not pass through a previously deployed stent.No resistance was encountered during delivery and no excessive force was used.It was reported that stent deformation occurred during positioning and then retracting.No patient injury reported.
Additional Manufacturer Narrative
Lesion was a high grade lesion (80-95%).The lesion was not pre-dilated.The procedure was completed using another medtronic 3.0x18 integrity stent.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.
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: 6394284
• Report Number: 9612164-2017-00258
• Device Sequence Number: 10978232
• Product Code: MAF
• UDI-Device Identifier: 00613994798503
• UDI-Public: 00613994798503
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 03/21/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/08/2017
• Device Catalogue Number: INT30018UX
• Device Lot Number: 0007644362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2017
• Initial Date Received by Manufacturer: 02/09/2017
• Supplement Date Received by Manufacturer: Not provided; 03/21/2017
• Initial Report FDA Received Date: 03/10/2017
• Supplement Report FDA Received Date: 04/19/2017; 09/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR