MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 2.25/26; CORONARY DRUG-ELUTING STENT

Model Number 364505

Device Problem Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/31/2023

Event Type  malfunction  

Manufacturer Narrative

Combination product: yes.

Event Description

An orsiro drug-eluting stent system was selected for treatment.A critical lesion with 90 percent stenosis degree in the middle third of the moderately tortuous lad was pre-dilated with a 2.0 x 15 balloon.The first 2.25/26 orsiro stent was implanted at 10 atm.At the time of balloon retraction after deflation, the stent did not detach and was pulled into the initial third of the lad.The second 2.25/26 orsiro stent (reported separately) was positioned at the lesion site, but the same occurred, and the second stent was pulled to the distal edge of the first stent.The intervention was completed with balloon dilatation at low pressure, leaving no residual lesion.

Manufacturer Narrative

Combination product: yes.The complaint instruments were not returned.Therefore, no technical investigation on the subject could be performed.The product release documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.In addition, videos taken from the angiographic material were reviewed.The videos provided show the two migrated stents in the proximal lad.However, the actual complaint events (incl.Balloon deflation, pullback etc.) are not visible.Review of the angiographic material did therefore not lead to any further information regarding the nature of the complaint.Review of the product release documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.Based on the conducted investigations, no material or manufacturing related root cause could be determined.Please note that the ifu advises the user to slightly advance and retract the delivery system carefully if the deflated balloon cannot be easily withdrawn from the wall apposed stent.

• Brand Name: ORSIRO 2.25/26
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 17214034
• MDR Text Key: 318019810
• Report Number: 1028232-2023-03206
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130411708
• UDI-Public: (01)07640130411708(17)2404
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: P170030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2024
• Device Model Number: 364505
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 03222770
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2023
• Initial Date FDA Received: 06/27/2023
• Supplement Dates Manufacturer Received: 08/15/2023
• Supplement Dates FDA Received: 08/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1