MAUDE Adverse Event Report: MEDTRONIC IRELAND RESOLUTE INTEGRITY RX; STENT, CORONARY, DRUG-ELUTING

Catalog Number	RSINT25030UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 a resolute integrity drug eluting stent to treat a lesion located in the (b)(6) branch which was reported to be moderately tortuous and severely calcified.No damage was noted to packaging and no issues were noted when removing the devices from the tray.The device was inspected with no issues identified.Negative prep was not performed.The lesion was pre-dilated.It was reported that during positioning/advancement of the stent, stent deformation occurred.The physician pulled back to adjust the position and the stent snagged on a piece of calcium.The stent was removed and it was noted that there was some deformation of the stent.Resistance was not encountered when advancing the device and no excessive force was used during delivery.The stent was replaced with another 2.5 x 30 resolute integrity drug eluting stent.No patient injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE INTEGRITY RX
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6632997
• Report Number: 9612164-2017-00744
• Device Sequence Number: 18835707
• Product Code: NIQ
• UDI-Device Identifier: 00643169037526
• UDI-Public: 00643169037526
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P110013
• 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): 05/15/2017

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: 03/08/2019
• Device Catalogue Number: RSINT25030UX
• Device Lot Number: 0008527394
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/15/2017
• Supplement Date Received by Manufacturer: 05/15/2017
• Initial Report FDA Received Date: 06/12/2017
• Supplement Report FDA Received Date: 10/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1