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

Catalog Number	RSINT25018UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Stroke/CVA (1770); Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)
Date of Event	02/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The physician intended to use a resolute integrity drug eluting stent.The target lesion was located in the left main coronary artery.No issues removing the sheath.Device was inspected with no issues noted.Lesion was pre-dilated.Inflation device remained on neutral during delivery of the stent.Device did pass through a previously deployed stent.Resistance was noted advancing the device to the lesion, but no excessive force was used.It was reported that during withdrawal of the device in the vessel/guide catheter, part of the stent fell off due to an issue with the guideliner not the resolute stent.This occurred in the left main coronary artery.The physician retrieved the stent with a snare and the patient was reported to be 'fine'.
Additional Manufacturer Narrative
It was reported that when the physician inserted a resolute integrity rx drug eluting stent into the artery, it was determined that it was the wrong size.The stent was reported to not be visible under fluoro but the balloon was intact.The physician suspected that the stent was retained in the guide catheter.The balloon was inflated to see if the stent could be visualized but was unsuccessful.The guide and guide catheter was removed and the physician attempted to locate the stent by cutting the guide catheter using a sterile scissors.The stent could not be located due to the material the guide was made of.It was unknown if the stent was present in the guide or not.The physician continued the procedure by inserting a new guide and performed hd ivus but could not visualize the stent in the patient's body.It was reported that a 3.0x12mm resolute integrity was also listed as deployed.It is unknown which of the two devices were involved in the reported event.The patient was brought back in to have the device removed.The stent was retrieved in fragments.Stroke code was called after stent removal due to neuro symptoms.Symptoms reported as abated and no further issues reported.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: 6401878
• Report Number: 9612164-2017-00264
• Device Sequence Number: 10894716
• Product Code: NIQ
• UDI-Device Identifier: 00643169037373
• UDI-Public: 00643169037373
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2017

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: 02/05/2018
• Device Catalogue Number: RSINT25018UX
• Device Lot Number: 0007926088
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/13/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/14/2017
• Supplement Report FDA Received Date: 06/13/2017
• 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: 75 YR