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

Catalog Number	RSINT22522UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Embolism (1829)
Date of Event	03/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An attempt was made to use one resolute integrity rx coronary drug eluting stent to treat a mildly tortuous and calcified lesion, with 90% stenosis, located in the proximal left anterior descending artery.There were no abnormalities in relation to the anatomy.There was no damage noted to packaging.There were no issues noted when removing the device from the hoop/tray.The device was inspected with no issues identified.Negative prep was not performed.The lesion was pre-dilated.The device did not pass through a previously-deployed stent.Resistance was encountered when advancing the device.Excessive force was not used during delivery.It was reported that the device failed to cross the target lesion.An attempt was made to remove the device and the stent dislodged in the right radial side of the wrist.A snare was used to successfully retrieve the stent and the procedure was completed using a resolute coronary drug eluting stent 225mm x 12mm.Patient status post-procedure is alive with no injury.
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: 7479116
• Report Number: 9612164-2018-00960
• Device Sequence Number: 238951
• Product Code: NIQ
• UDI-Device Identifier: 00643169037434
• UDI-Public: 00643169037434
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/14/2018

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: 01/23/2019
• Device Catalogue Number: RSINT22522UX
• Device Lot Number: 0008463758
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/04/2018
• Supplement Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 05/02/2018
• Supplement Report FDA Received Date: 09/14/2018
• 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: 70 YR
• Patient Weight: 63