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

Model Number	RSINT22508UX
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Positioning Problem (3009)
Health Effect - Clinical Codes	Intimal Dissection (1333); Death (1802); Occlusion (1984); Patient Problem/Medical Problem (2688)
Date of Event	03/27/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the physician was attempting to use a resolute integrity rx drug eluting stent (2.25x12) to treat a mid circumflex vessel just after an acute angle off the left main with severe calcification.The device had been removed from packaging and inspected with no issues noted.The lesion was pre-dilated using a sprinter legend balloon and the physician attempted to deliver the resolute integrity stent.It was reported that the stent would not cross the severe 90 degree bend.The stent was removed and it was noted that a few stent struts had lifted and deformed.The lesion was pre-dilated again and the physician attempted to deliver another resolute integrity stent (2.25x8) but the device also failed to cross.During removal of the second resolute the stent dislodged and was visualized in the acute bend of the cx.It was reported that shortly after, the cx vessel had no flow ( timi 0 ) and cpr was performed.The cx had collateral that supplied a total rca.Flow in the cx was never resumed.Then in the distal lm and proximal lad the physician observed a disruption or dissection which was stented successfully with a non mdt stent.The physician felt the disruption might have been due to the lifted struts from the first resolute 2.25 x 12 stent when he withdrew back through the lm and into the mdt guide catheter or it could have been the guide catheter.The patient could not be revived after cpr and suffered death.Physician stated cause of death was abrupt closure of the circumflex artery which was providing collateral circulation to a cto of the rca and flow reduction from disruption of the proximal lad.
Additional Manufacturer Narrative
Patient history includes smoking, hypertension, prior mi, family history of cad, chronic lung disease and dyslipedemia.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
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
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
Cine image review: the patient had very complex coronary disease with clear calcification in the proximal lad near the origin of the heavily diseased cx.The rca territory is collateralized from the cx and lad, and via a large septal artery.The lm is also tapered by disease with calcification.The rca is occluded in the mid-vessel with bridging antegrade collaterals.The lvgram is attempted with a rca catheter which shows reasonable function in the anterior and inferior walls even with induced ectopics.A guidewire is passed via the lm, proximal cx to the first om and a small balloon is inflated in the proximal segment of the cx.No rotablation is attempted in the lm calcification or around the bend into the cx nor is a proximal inflation carried out initially in the cx origin.A backup catheter is then place to the distal lm.After removal of the backup catheter there is disruption in the mid-lm where reduced radiopacity is seen with a clear line across the lm suggestive of dissection or calcium disruption.After attempted stent placement the proximal lad is disrupted, even with a wire in place and this is plaque shift or dissection.Slow flow is now present in lad and lv function has diminished.After this there is an episode of no flow in the lm, then the lad is reopened but the cx has lost flow.The cine images didn't capture any further procedure.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: 6517869
• Report Number: 9612164-2017-00495
• Device Sequence Number: 867333
• Product Code: NIQ
• UDI-Device Identifier: 00643169037397
• UDI-Public: 00643169037397
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup,Followup
• Report Date (Section B): 09/07/2017

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: 11/11/2018
• Device Model Number: RSINT22508UX
• Device Catalogue Number: RSINT22508UX
• Device Lot Number: 0008373379
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/27/2017
• Supplement Date Received by Manufacturer: Not provided; 05/11/2017; 05/11/2017; 09/07/2017
• Initial Report FDA Received Date: 04/25/2017
• Supplement Report FDA Received Date: 06/09/2017; 09/07/2017; 09/07/2017; 10/06/2017
• 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: Death; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 62