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	Patient Problem/Medical Problem (2688)
Date of Event	08/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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.
Event or Problem Description
The physician intended to use a resolute integrity stent to treat a lesion.No stent on fluoro, no stent found in body, bed or floor.
Additional Manufacturer Narrative
Additional information : the physician intended to use a resolute integrity drug eluting stent to treat a lesion in the mid circumflex.The lesion exhibited 95% stenosis.The lesion was pre-dilated.An attempt was made to deliver the device with the use of additional wires however the stent did not initially cross, the device was removed and the lesion was pre-dilated again.After inflation, no stent was visualized on fluoroscopy.Location of the stent is unknown.The procedure was completed with three other stents.No clinical sequelae reported.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: 6878629
• Report Number: 9612164-2017-01298
• Device Sequence Number: 13758389
• Product Code: NIQ
• UDI-Device Identifier: 00643169037434
• UDI-Public: 00643169037434
• Combination Product (Y/N): N
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2017

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: 01/25/2019
• Device Catalogue Number: RSINT22522UX
• Device Lot Number: 0008469805
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/22/2017
• Supplement Date Received by Manufacturer: 10/19/2017
• Initial Report FDA Received Date: 09/20/2017
• Supplement Report FDA Received Date: 10/20/2017
• 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: 68 YR
• Patient Weight: 72