MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION 3.5/18; CORONARY DRUG-ELUTING STENT

Model Number 419123

Device Problem Fluid/Blood Leak (1250)

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

Event Date 05/04/2023

Event Type  malfunction  

Manufacturer Narrative

Combination product: yes.

Event Description

An orsiro mission drug-eluting stent system was selected for treatment of a mildly calcified lesion (80 percent stenosis degree) in the proximal da.When starting inflation, rapid deflation was observed.Upon reaching the required atm, retrograde contrast leak (in the proximal part) was observed on the monitor.The delivery system was removed, and the stent was post-dilated with another balloon.The patient evolves favorably.

Manufacturer Narrative

Combination product: yes.The returned product was subjected to a detailed technical analysis and the corresponding product release documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.In addition, a photograph taken from the angiogram was reviewed.The technical investigation confirmed that the balloon has been inflated and was deflated in the as-returned state.Functional testing was performed by inflating the instrument up to 10 atm (np) during which a fine jet of water was seen to emerge from the proximal balloon portion.Microscopic inspection revealed a pinhole in the balloon material above proximal radiopaque marker.Scratches were observed in close vicinity to the pinhole which have likely been caused by a hard, sharp-edged object such as e.G.Anatomical structure.The photograph taken from the angiogram shows the balloon being inflated in the proximal lad with contrast medium leaking from the proximal balloon portion.However, the photograph did not provide any further relevant information with regards to the root cause 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.In addition to visual inspections each instrument is tested for air tightness by means of a helium leak test.We can therefore confirm that the instrument was delivered in a leak-proof condition.Based on the conducted investigations, no manufacturing or material related root cause could be determined.The root cause is most likely related to the patients anatomy.

• Brand Name: ORSIRO MISSION 3.5/18
• 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: 17075216
• MDR Text Key: 317672620
• Report Number: 1028232-2023-02832
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130441835
• UDI-Public: (01)07640130441835(17)2403
• 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: 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2024
• Device Model Number: 419123
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 03224133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2022
• 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