MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO; CORONARY DRUG ELUDING STENT

Catalog Number SEE MODEL NO.

Device Problem Fracture (1260)

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

Event Date 03/23/2023

Event Type  malfunction  

Manufacturer Narrative

Combination product: yes.

Event Description

An orsiro mission drug-eluting stent system was selected for treatment of a predilated lesion in a graft.The delivery balloon full inflated per normal.When they removed the delivery system the physician noticed that 2/3 of the stent remained proximal on the balloon.1/3 of the stent deployed into the body and 2/3 was left on the balloon when removed.They had a guideliner down and had issues with it throughout the case.Before deploying the stent, they had dilated the guideliner with a balloon because the balloon was getting hung up on the distal end of guideliner.They went down with a competitors stent and over-stented the orsiro part.

Manufacturer Narrative

Combination product: yes.The complaint instrument was not returned to biotronik.No product size, ref or lot number was reported.Therefore, the product release documentation of the last three orsiro mission lots that were delivered to the hospital prior to the reported event date was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.In addition, a video taken from the angiogram was reviewed.The video taken from the angiogram shows a stent system positioned in a tortuous vessel before and during inflation.Unfortunately, the quality of the video provided is rather poor and contains no relevant information such as time stamps, planes etc.The actual complaint event is not visible.A stent fracture can neither be confirmed nor denied.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 of the device being subject to this complaint, no material or manufacturing related root cause could be determined.It should be noted that, according to the ifu, orsiro mission is indicated for improving coronary luminal diameter in the native coronary arteries.

• Brand Name: ORSIRO
• Type of Device: CORONARY DRUG ELUDING 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: 16904179
• MDR Text Key: 314931772
• Report Number: 1028232-2023-02347
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P170030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/19/2023

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 Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2023
• Initial Date FDA Received: 05/10/2023
• Supplement Dates Manufacturer Received: 07/17/2023
• Supplement Dates FDA Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization
• Patient Sex: Male