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

Catalog Number	RSINT35022UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was indicated on a non complaint product replacement form that a resolute integrity rx coronary, drug eluting stent was unable to cross and when removed had damaged struts.The lesion was pre-dilated.It was a calcified and tortuous mid rca.No patient injury is reported.
Additional Manufacturer Narrative
The target lesion was severely calcified and severely tortuous.The device was inspected with no issues noted.Negative prep was performed with no issues.The lesion was pre-dilated with a 1.25x10mm sprinter balloon and 2.75x20mm nc euphora balloon.The device did not pass through a previously-deployed stent.Resistance was encountered when advancing the device.Excessive force was not used during delivery.It was reported that one of the stent struts was raised when inspected on removal.The lesion was then stented with a 2.75x18mm resolute integrity stent.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: 8694924
• Report Number: 9612164-2019-02314
• Device Sequence Number: 1832041
• Product Code: NIQ
• UDI-Device Identifier: 00643169037137
• UDI-Public: 00643169037137
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P110013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2019

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: 12/16/2020
• Device Catalogue Number: RSINT35022UX
• Device Lot Number: 0009494718
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/07/2019
• Supplement Date Received by Manufacturer: 06/28/2019
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 07/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR