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

Catalog Number	RSINT22526UX
Medical Device Problem Codes	Burst Container or Vessel (1074); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	02/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The physician intended to implant a resolute integrity drug eluting stent.The target lesion was located in the mid circumflex (cx) artery and was reported to be severely tortuous and mildly calcified with 70-80% stenosis.No damage to packaging was noted and no issues removing the device from the hoop/tray were recorded.There were no issues removing the protective sheath.The device was inspected with no issues noted.Negative prep was performed with no issues.The lesion was not pre-dilated and the device did not pass through a previously deployed stent.The inflation device remained on neutral pressure during delivery of the device.When advancing the device, resistance was encountered.Moderate force was used to advance the device.The device did not reach the target lesion.During attempted stent deployment, a balloon burst/leak/catheter leak was reported.This was noticed following the first inflation.There was blood in the inflation device.It cannot be confirmed if the balloon or catheter was leaking.The stent delivery balloon could only be inflated to 7 atm.It is reported that the stent embolised and the physician trapped the embolized stent with two other stents.No patient injury reported for this event.
Additional Manufacturer Narrative
During attempted stent deployment a balloon rupture occurred.The stent was partially deployed.Cine images received.The images capture the lesion site in the cx artery.The attempted delivery of the resolute integrity stent is visible from the images and resistance is encountered during the delivery of the device.The distal end of the stent can be seen to be partially expanded and the distal inner shaft marker pulled proximally, suggesting withdrawal of the delivery system.Slight bunching and flaring is evident of the proximal end of the stent at the tip of the guide catheter.The next images capture the dislodged stent in the vessel.The proximal and distal ends of the dislodged stent are flared.Unidentified stents are then deployed at the lesion site, proximal and distal to the dislodged stent.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.
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: 6375390
• Report Number: 9612164-2017-00234
• Device Sequence Number: 13643191
• Product Code: NIQ
• UDI-Device Identifier: 00643169037441
• UDI-Public: 00643169037441
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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,Followup
• Report Date (Section B): 03/03/2017

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: 08/11/2018
• Device Catalogue Number: RSINT22526UX
• Device Lot Number: 0008176189
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/03/2017
• Supplement Date Received by Manufacturer: Not provided; 03/03/2017
• Initial Report FDA Received Date: 03/03/2017
• Supplement Report FDA Received Date: 03/29/2017; 09/29/2017
• 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: 55 YR
• Patient Weight: 91