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

Catalog Number	RSINT25014UX
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Stenosis (2263); Patient Problem/Medical Problem (2688)
Date of Event	02/11/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the patient received a medtronic drug eluting stent to the left main to ramus during pci.It was reported approximately 9 months post implant the patient was admitted with cardiac symptoms.It was reported that the patient's stent had fractured resulting in failure of the device.Intervention was performed.The device was not explanted.Restenosis was noted, which was treated with ballooning.It is reported that the physician could not definitively conclude whether there was a stent fracture, or whether the stent in question was a medtronic stent.Stent fracture/occlusion noted in the ramus and the occlusion of the lm to ramus, successfully treated with tvr.
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: 6629620
• Report Number: 9612164-2017-00735
• Device Sequence Number: 1082592
• Product Code: NIQ
• UDI-Device Identifier: 00643169037366
• UDI-Public: 00643169037366
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/18/2017
• Device Catalogue Number: RSINT25014UX
• Device Lot Number: 0007473351
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/11/2017
• Supplement Date Received by Manufacturer: 05/11/2017
• Initial Report FDA Received Date: 06/09/2017
• Supplement Report FDA Received Date: 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR