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

Catalog Number	RSINT22512UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	04/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the physician was intending to use a resolute integrity device to treat a lesion in the mid to distal lm coronary artery.The vessel was non tortuous with mild calcification and exhibited 10% stenosis.No abnormalities were reported in relation to the patient¿s anatomy.No damage was noted to the packaging.No issues were noted when removing the device from the hoop/tray or when removing the protective sheath.The device was inspected and negative prep was performed with no issues noted.The lesion was pre-dilated.Resistance was encountered when advancing the device but no excessive force was used.The physician was stenting the lad with a resolute device of a different size.Upon inflation the delivery system moved due to the patients heavy breathing.The physician ended up stenting a little into the left main.It was reported that some of the stent was hanging out.The physician flared the end of the stent and ballooned the proximal end of the circ with an sc balloon and then attempted to stent the circ.Upon entering the circ with the stent it was reported that the physician felt resistance and pulled the delivery system back.The inflation device remain on neutral pressure during delivery of the device.Upon removal he noticed that the stent was no longer on the balloon and was in the left main.The physician attempted to snare the stent with multiple sized snares and also attempted to wire the stent and inflate a balloon distally to it to try and catch it and bring it back to the guide.All attempts were unsuccessful and the physician then proceeded to crush the stent in the left main.The physician then stented the circ and the left main with 2 more resolute devices.Ivus was performed and it showed good opposition of the stents and minimal narrowing where the stent was crushed.Patients as of today is doing fine.
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: 6559585
• Report Number: 9612164-2017-00579
• Device Sequence Number: 16167528
• Product Code: NIQ
• UDI-Device Identifier: 00643169037403
• UDI-Public: 00643169037403
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 04/13/2017

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: 01/04/2018
• Device Catalogue Number: RSINT22512UX
• Device Lot Number: 0007881707
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/13/2017
• Supplement Date Received by Manufacturer: 04/13/2017
• Initial Report FDA Received Date: 05/11/2017
• Supplement Report FDA Received Date: 10/03/2017
• 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