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

Catalog Number	RSINT22530UX
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
Event or Problem Description
Patient had a stent placed previously (2008) in the mid-prox lad.It was reported that the physician was attempting to use a resolute integrity rx drug eluting stent to treat a moderately calcified and tortuous distal lad lesion exhibiting 80% stenosis.No damage noted to device packaging.The device was inspected with no issues noted.The lesion was pre-dilated.During the procedure, it was reported that the device passed through a previously deployed stent in the mid-prox lad on a curve.Resistance was encountered and excessive force used during delivery.It was reported that the resolute integrity stent got stuck in the previously deployed stent.A balloon was used in an attempt to remove the device without success.The physician pulled back hard and the delivery system came out without the stent on the delivery system balloon.The physician crushed the un-deployed stent in to the lad using a non-mdt stent.
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: 6289056
• Report Number: 9612164-2017-00086
• Device Sequence Number: 10955826
• Product Code: NIQ
• UDI-Device Identifier: 00643169037335
• UDI-Public: 00643169037335
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 01/04/2017

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: 04/25/2018
• Device Catalogue Number: RSINT22530UX
• Device Lot Number: 0008028316
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/04/2017
• Supplement Date Received by Manufacturer: 01/04/2017
• Initial Report FDA Received Date: 01/31/2017
• 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
• Patient Age: 53 YR