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

Catalog Number	RONYX35026UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Death (1802); Heart Failure (2206); Patient Problem/Medical Problem (2688)
Date of Event	02/20/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A 3.5 x 26 mm resolute onyx drug eluting stent was intended to be used during a procedure, to treat a lesion located in the mid/distal rca, exhibiting moderate tortuosity and no calcification.Initial images revealed in-stent re-stenosis was present in the mid/distal rca.There was no damage noted to device packaging.There were no issues noted when removing the device from the hoop.The device was inspected with no issues noted.No difficulties were noted while removing the protective sheath on the initial introduction of the product, and the stent was inspected post-removal of the sheath.Negative prep was not performed.The device remained on neutral pressure during the delivery of the device.The lesion was pre-dilated.The device did pass through a previously deployed stent-there were multiple previously deployed stents in place from the proximal rca though mid/distal rca.Resistance was encountered when advancing the device, and excessive force was used during delivery.It is reported that stent dislodgement occurred during removal, following a failed delivery.Previously to the dislodgement, the physician had gone in with the 3.5 x 26 mm resolute onyx drug eluting stent prior to dilating the vessel, and the stent was unable to advance past the mid rca.This stent was removed intact on the balloon.The lesion was then pre-dilated with a 3.0 x 15 mm nc euphora balloon, with serial dilations starting with the distal rca just proximal to the crux of the rca pulling back to the mid rca.The nc euphora was then removed and another attempt was made to advance the 3.5 x 26 mm resolute onyx drug eluting stent.The stent would not pass through the mid rca restenosis.A balloon was re-introduced and further dilations occurred.The 3.5 x 26 mm onyx was reintroduced and was unable to advance.The medtronic guide catheter was exchanged for an al10, and the short sheath was also exchanged for a longer 24 mm sheath in the right femoral artery.A shorter stent, a 3.5 x 15 mm onyx was introduced and was successfully advanced to the distal rca.This stent was deployed without incident.The previous 3.5 x 26 mm onyx was reintroduced and again unable to advance past the mid rca despite multiple attempts.The stent balloon and wire were removed from the guide.The stent was noted to not be on the balloon upon removal.Imaging revealed the stent was in the abdominal aorta.The physician introduced a ev3 gooseneck snare to recapture the stent, but was unable to snare the stent.The stent was observed moving distally in the abdominal aorta.The physician repeated attempts to snare the 3.5 x 26 mm onyx as the stent travelled more and more distally.The physician exchanged a 6 x 24 mm sheath for 6 x 45 mm non-medtronic sheath for placement in contralateral lower extremity.The stent was attempted to be snared with 12-20 mm non-medtronic snare unsuccessfully and noted to be in left internal iliac.The physician deployed a 7 x 37 mm visipro stent in left internal iliac, trapping the 3.5 x 26 mm onyx from further migration.A 6 x 40 mm non-medtronic balloon used to post dilate stent.The patient expired two days after procedure.The patient expired due to chronic heart failure.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Image review: the returned procedural images capture the patient lesion condition as reported by the account.Pre-dilation is captured in both the distal and mid rca in a previously deployed stent.The images do not capture the attempted delivery or reported stent dislodgement of the complaint 3.5 x 26mm stent; however, the dislodged stent is visible in the abdominal aorta.Images capture the dislodged resolute onyx stent being trapped by a non-medtronic stent.The returned images do not capture the reported successful implantation of the 3.5 x 15mm stent.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 ONYX RX
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7352723
• Report Number: 9612164-2018-00525
• Device Sequence Number: 1470621
• Product Code: NIQ
• UDI-Device Identifier: 00643169557109
• UDI-Public: 00643169557109
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/05/2018

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: 10/25/2019
• Device Catalogue Number: RONYX35026UX
• Device Lot Number: 0008847456
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/20/2018
• Supplement Date Received by Manufacturer: 05/31/2018; 07/17/2018; 08/08/2018
• Initial Report FDA Received Date: 03/20/2018
• Supplement Report FDA Received Date: 06/28/2018; 08/09/2018; 10/05/2018
• 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: Death; Required Intervention