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

Catalog Number	RSINT30026UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the physician attempted to implant a resolute integrity drug eluting stent in the circumflex artery.Lesion exhibited 90% stenosis, minimal tortuosity and was highly calcified.No anatomical abnormalities were reported.No damage was noted to the packaging and no issues were noted when removing the device from the hoop.The device was inspected post-removal from packaging with no issues noted.Resistance was noted in advancing the device and excessive force is reported to have been used.The physician tried to cross, but the lesion was very calcified.The stent strut is reported to have been bent (deformed) as a result of attempting to cross the lesion.The deformation was noted when the physician removed the device from the patient.The physician completed the procedure with another resolute integrity rx drug eluting stent.No patient injury was reported.
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: 6240218
• Report Number: 9612164-2017-00033
• Device Sequence Number: 865863
• Product Code: NIQ
• UDI-Device Identifier: 00643169037175
• UDI-Public: 00643169037175
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 12/16/2016

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: 08/23/2018
• Device Catalogue Number: RSINT30026UX
• Device Lot Number: 0008188246
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/16/2016
• Supplement Date Received by Manufacturer: 12/16/2016
• Initial Report FDA Received Date: 01/11/2017
• Supplement Report FDA Received Date: 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 85