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

Catalog Number	RSINT25026UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	01/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis: kinks were visible on the hypotube.Visual inspection confirmed that the stent was not present on the balloon.Stent crimp impressions were visible on the exposed balloon surface.The distal tip was slightly damaged.(b)(4).
Event or Problem Description
It was reported that the physician was attempting to use a resolute integrity drug eluting stent to treat a moderately calcified and mildly tortuous proximal cx lesion exhibiting 80% stenosis.No issues were noted with the device packaging.The device was removed from the hoop/ tray with no issues noted.The device was inspected with no issues noted.No difficulties removing the protective sheath.Stent inspected post sheath removal with no issues noted.Negative prep was performed successfully.During the procedure, the device did not pass through a previously deployed stent.No resistance was encountered during advancement or excessive force required.It was reported that the physician felt the stent get caught on a piece of calcium which resulted in the stent dislodging from the delivery balloon.This occurred before reaching the lesion.The physician maintained wire position and was able to use a regular 2.50 balloon to deploy the stent before it caused a blockage and used an nc balloon to inflate the stent to 3.25mm.No patient injury reported.
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: 6303173
• Report Number: 9612164-2017-00104
• Device Sequence Number: 16343022
• Product Code: NIQ
• UDI-Device Identifier: 00643169037519
• UDI-Public: 00643169037519
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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,Followup
• Report Date (Section B): 01/09/2017

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: 08/11/2018
• Device Catalogue Number: RSINT25026UX
• Device Lot Number: 0008176190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2017
• Initial Date Received by Manufacturer: 01/09/2017
• Supplement Date Received by Manufacturer: 01/09/2017
• Initial Report FDA Received Date: 02/06/2017
• Supplement Report FDA Received Date: 09/28/2017
• 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