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

Model Number RONYX22530UX

Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Device Damaged by Another Device (2915); Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348)

Event Date 01/13/2020

Event Type  malfunction  

Manufacturer Narrative

Product analysis summary: device returned for evaluation. Two dislodged stents returned for analysis, 2. 25 x 30 resolute onyx (pli 10) and 2. 25 x 38mm resolute onyx (pli 20). Extensive deformation was evident to stents with struts severely stretched. Fracture points were evident to the stent wires. It was not possible to identify pli 10 or 20 due to the deformation. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

A 2. 25 x 30 resolute onyx rx coronary, drug eluting stent (pli10) was used to treat a severely calcified, mildly tortuosity lesion exhibiting 80% stenosis in the proximal right coronary artery (rca). There was no issues removing the device from the hoop. The device was inspected with no issues. The lesion was pre dilated. The device did not pass through a previously deployed stent. Resistance was encountered. Excessive force was not used. An attempt was then made to deliver a 2. 25 x 38 mm resolute onyx rx coronary, drug eluting stent (pli20) through a proximal 2. 25 x 30 resolute onyx rx coronary, drug eluting stent (pli10) to a distal lesion the stent could not pass the proximal stent. There was no damage noted to the packaging of the 2. 25 x 38mm device (pli20). The 2. 25 x 38mm device was inspected with no issues, negative prep was not performed. It was reported that the 2. 25 x 38 resolute stent (pli 20) deformed inside the 2. 25 x 30 resolute onyx rx stent (pli 10). During removal of the 2. 25 x 38mm deformed stent (pli20) it caught on the 2. 25 x 30mm stent (pli10) and the 2. 25 x 30mm stent (pli10) dislodged. Both stents were snared in the aorta and removed. The lesion was then treated with a 2. 0 x 22 and 2. 25 x 38 resolute onyx rx coronary, drug eluting stent. The patient is alive with no injury.

• Brand Name: RESOLUTE ONYX RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 9646340
• Report Number: 9612164-2020-00478
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169556751
• UDI-Public: 00643169556751
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/01/2020
• Device Model Number: RONYX22530UX
• Device Catalogue Number: RONYX22530UX
• Device Lot Number: 0009123119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/07/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 05/02/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Age: 68 YR
• Patient Outcome(s): Required Intervention