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

Catalog Number	INT40015UX
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
The physician intended to use an integrity bare metal stent to treat a lesion.The device was inspected before use with no issues noted.It is reported that the stent shaft separated.The detachment occurred during advancement of the device.The detachment occurred on the proximal shaft.No resistance was encountered during delivery of the device to the lesion site.The detached portion of the device was successfully removed from the patient by removing the guide.The stent was replaced with another mdt stent.No injury reported.
Additional Manufacturer Narrative
Additional information: the balloon was not inflated.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: there was no luer returned with the device.The device returned with a detachment on the hypotube 67.5cm proximal to the guidewire entry port.The hypotube material was oval and jagged at the detachment site.Kinks were evident on the hypotube proximal to the detachment site.The stent was positioned on the balloon between the marker bands as per specifications.No deformation was evident to stent wraps.Slight deformation 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: 6790986
• Report Number: 9612164-2017-01101
• Device Sequence Number: 11155682
• Product Code: MAF
• UDI-Device Identifier: 00613994798633
• UDI-Public: 00613994798633
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 12/07/2017

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: 11/17/2018
• Device Catalogue Number: INT40015UX
• Device Lot Number: 0008379469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2017
• Initial Date Received by Manufacturer: 07/15/2017
• Supplement Date Received by Manufacturer: 08/04/2017; 11/10/2017
• Initial Report FDA Received Date: 08/14/2017
• Supplement Report FDA Received Date: 09/01/2017; 12/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1