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

Catalog Number	RSINT25018UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	11/17/2016
Type of Reportable Event	Death
Event or Problem Description
Patient was sent home on maximum medical therapy as surgery was not an option.The angina persisted and the patient returned to the er 3 days later with unrelenting chest pain.Diagnostic catheter showed a severely calcified non-tortuous ostium cx lesion.Ivus showed significant plaque burden.The left main was pre-dilated with an nc euphora balloon with no issues noted.The physician then attempted to implant a 3.0mmx22mm resolute integrity stent from the lm to the circumflex.The device was inspected and negative prep performed with no issues noted.The stent did not pass through a previously deployed stent.No resistance was encountered during delivery and no excessive force used.It was reported that when they deployed the resolute integrity stent the patient had a spiral dissection in the circumflex and started to loose circulation.It was reported that the physician believes that the calcified area of the vessel was affected by the stent placement.It was reported that the physician attempted to place 2 x resolute integrity 2.50mmx18mm stents in the circumflex to salvage the artery.Both stents passed through previously deployed stents.No resistance or excessive force was used during delivery for the first of these 2 stents while no excessive force was reported for the next stent.Both devices were inspected and negative prep with no issues noted.It was reported that the attempt to salvage the artery did not maintain circulation and the patient expired.Attempts were made to revive the patient but this was hampered with a lv function of 25%.The patient was on dapt at the time of the event.Physician determined the cause of death as follows 'dissection in circumflex caused short period of no reflow which resulted in hemodynamics compromise and electromechanical disassociation which couldn't be restored after successful placement of left main and circumflex stents restoring coronary blood flow".Physician believes that the dissection was related to difficult lesion morphology.
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.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: 6176777
• Report Number: 9612164-2016-01309
• Device Sequence Number: 255444
• Product Code: NIQ
• UDI-Device Identifier: 00643169037373
• UDI-Public: 00643169037373
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P110013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2016

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: 08/09/2018
• Device Catalogue Number: RSINT25018UX
• Device Lot Number: 0008171947
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/17/2016
• Supplement Date Received by Manufacturer: 11/17/2016
• Initial Report FDA Received Date: 12/15/2016
• Supplement Report FDA Received Date: 09/27/2017
• 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
• Patient Age: 78 YR