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

Catalog Number	RSINT30015UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Myocardial Infarction (1969); Thrombus (2101)
Date of Event	10/26/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician implanted 3 resolute integrity rx coronary drug eluting stents in the proximal, mid lad which had severe tortuosity and calcification with 100% stenosis (cto).There were no abnormalities reported in relation to the lesion.No damage was noted to the packaging and no issues were noted when removing the device from the hoop/tray.The device was not inspected and negative prep was performed with no issues.The lesion was pre-dilated.The device did pass through a previously deployed stent.Resistance was encountered when advancing the device and excessive force was used during delivery.A resolute integrity des (3.0x15) was implanted in the mid lad and post-dilated with a nc euphora (3.25x8).Another resolute integrity des (3.0x15) was implanted in the prox lad and post-dilated with the same nc euphora balloon.A resolute integrity des (2.75x30) was implanted in the mid rca and was post-dilated by the same nc euphora balloon.It was reported that 7 days post mdt stent implantation, the patient came into the er with a stemi and vt (ventricular tachycardia).The patient received defibrillation twice, a cvl (central venous line), cpr with balloon pump and lhc (left heart catheterisation) which showed sat in the proximal lad in the recently deployed mdt stent.The patient died on the same day.Patient continued to smoke and did not take plavix medication 48 hours prior to event.The cause of death is as a result of the patient's blood clotting condition.The physician has not commented on the relationship between the event and the relevant device.

• 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: 7052411
• Report Number: 9612164-2017-01650
• Device Sequence Number: 913128
• Product Code: NIQ
• UDI-Device Identifier: 00643169037502
• UDI-Public: 00643169037502
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P110013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/22/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/26/2019
• Device Catalogue Number: RSINT30015UX
• Device Lot Number: 0008652251
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2017
• Initial Report FDA Received Date: 11/22/2017
• 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: Death; Hospitalization
• Patient Age: 68 YR
• Patient Weight: 62