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

Catalog Number	RSINT22526UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician was attempting to treat a moderately tortuous and moderately calcified lesion in the mid obtuse marginal which had 99% lesion stenosis using a resolute integrity drug eluting stent.The vessel diameter was 2.5 mm and the lesion length was 26 mm.There was no damages noted to packaging, that is, shelf carton, hoop/tray.There were no issues noted when removing device from the hoop/tray.The device was inspected and negative prep was performed with no issues noted.The lesion was pre-dilated.The device did not pass through previously deployed stent.Resistance was encountered when advancing the device and excessive force was not used during delivery.It was reported that the stent did not cross the lesion, it was pulled from the body and inspected.Physician then discovered a stent strut protruding and chose to use a different stent.There was no injury to the patient or clinical sequelae reported.
Additional Manufacturer Narrative
Evaluation summary: numerous kinks were apparent along the hypotube.The stent was positioned on the balloon between the marker bands as per specifications.Deformation was evident to the 19th, 20th and 21st stent wraps, with struts raised and overlapping.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: 7174415
• Report Number: 9612164-2018-00033
• Device Sequence Number: 1250250
• Product Code: NIQ
• UDI-Device Identifier: 00643169037441
• UDI-Public: 00643169037441
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 05/24/2018

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: 05/31/2019
• Device Catalogue Number: RSINT22526UX
• Device Lot Number: 0008657106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• Initial Date Received by Manufacturer: 12/11/2017
• Supplement Date Received by Manufacturer: 05/03/2018
• Initial Report FDA Received Date: 01/09/2018
• Supplement Report FDA Received Date: 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 77