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

Catalog Number	RONYX30012W
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Embolism (1829); Patient Problem/Medical Problem (2688)
Date of Event	06/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Still cine images were received from the account.The images capture a mildly calcified and moderately tortuous proximal lad lesion exhibiting 95% stenosis.The attempted delivery of the resolute onyx 3.0x12mm device is visible from the images.The dislodged stent is visible in the vessel as the delivery system is advanced distally in the vessel.The mechanism by which the stent dislodged cannot be confirmed by the still images.There are no images capturing the reported detachment of the catheter.The dislodgment reported by the account can be confirmed from the images.
Event or Problem Description
The patient was presented with stemi.It was reported that the physician was attempting to use a resolute onyx otw drug eluting stent to treat a mildly calcified and moderately tortuous proximal lad lesion exhibiting 95% stenosis.No damage to device packaging and no issues removing the device from the hoop.The stent was inspected post removal of the protective sheath with no issues noted.Negative prep was not performed.The lesion was pre-dilated.During the procedure, the stent did not pass through a previously deployed stent.Resistance was encountered during delivery and excessive force used.The inflation device remained on neutral pressure during the delivery of the device and the balloon was not inflated to deploy the stent.It was reported that the stent came off the balloon while trying to deliver to lesion.The balloon was used to try and catch stent and bring it back to sheath and was retrieved to a certain point but was not able to be removed from the body.The stent eventually became lodged in profundity and embolized there.Resolute onyx balloon catheter shaft also broke during this process.The detachment occurred mid-catheter.The detached portion of the device was successfully removed used by pulling the entire guidewire guide catheter out poba was carried out as intervention.The dislodged stent was not removed from the patient.The emboli was not treated.The patient is stable.

• Brand Name: RESOLUTE ONYX OTW
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6685604
• Report Number: 9612164-2017-00851
• Device Sequence Number: 16168703
• Product Code: NIQ
• UDI-Device Identifier: 00643169602496
• UDI-Public: 00643169602496
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• 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
• Report Date (Section B): 06/08/2017

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: 02/13/2019
• Device Catalogue Number: RONYX30012W
• Device Lot Number: 0008493580
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2017
• Initial Report FDA Received Date: 07/05/2017
• 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: Life Threatening
• Patient Age: 60 YR
• Patient Weight: 88