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

Device Problems Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 09/10/2020

Event Type  Injury  

Manufacturer Narrative

Journal article: partial stent extraction 14 months after stent implantation as a complication of cutting balloon authors: keisuke shoji, kan zen, kenji yanishi, satoaki matoba journal: cardiovascular intervention and therapeutics year: 2021 reference: doi. Org/10. 1007/s12928-020-00704-z. If information is provided in the future, a supplemental report will be issued.

Event Description

An article titled - partial stent extraction 14 months after stent implantation as a complication of cutting balloon was submitted. A 2. 50mm resolute onyx coronary drug-eluting stent (des) was implanted to treat an unprotected subtotal occlusion of the left circumflex artery. Approximately 11 months later a 99% in-stent restenosis (isr) was treated with a drug coated balloon. Approximately 14 months post stent implantation, a symptomatic focal isr recurred and intravascular ultrasound (ivus) demonstrated stent recoil due to severe calcification. A non-medtronic cutting balloon was used to prepare the lesion before implanting a new des. Resistance was felt when removing the cutting balloon after complete deflation. Approximately 7 mm of the proximal stent was inadvertently removed along with the cutting balloon. The patient remained hemodynamically stable, and optical coherence tomography confirmed recoil and avulsion of the neointima. The new des (2. 75x12mm) was deployed at the extraction site. Final angiography and oct confirmed acceptable expansion of the stent. It was suspected that the cutting balloon flex point, which occurs every 5mm along the blade, became afixed to the proximal edge of the under expanded stent and caused the stent extraction.

• Brand Name: RESOLUTE ONYX RX
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12881103
• Report Number: 9612164-2021-04594
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: KG
• Patient Outcome(s): Required Intervention