MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION 2.75/22; CORONARY DRUG-ELUTING STENT

Model Number 419127

Device Problem Material Rupture (1546)

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

Event Date 11/08/2023

Event Type  malfunction  

Manufacturer Narrative

Combination product: yes.

Event Description

An orsiro mission drug-eluting stent system was selected for treatment of a moderately calcified lesion (98 percent stenosis degree) in the moderately tortuous proximal lad.The stent was placed in the lesion, and during inflation the balloon burst at 13 atm.Another balloon was used to complete the intervention.

Manufacturer Narrative

Combination product: yes.The returned product was subjected to a detailed technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.In addition, the angiographic material provided was reviewed.The angiographic material shows an inflated device, causing a bleeding/dissection at the proximal balloon portion.Thereafter, a stent system is inflated with a good angiographic result.Review of the angiographic material did not provide further relevant information regarding the root cause of the complaint.The technical investigation showed that the balloon has been inflated and was deflated in the as-returned state.During functional testing, a fine jet of water was seen to emerge from the proximal balloon portion.Microscopic inspection revealed a pinhole located about 10 mm distal to the proximal radiopaque marker.The pinhole follows a deep transversal scratch in the balloon surface which has likely been caused by a hard, sharp-edged object such as e.G., anatomical structure.Review of the production documentation confirmed that the device was manufactured according to specifications and passed all in-process and final inspections.In addition to visual inspections each device is tested for air tightness by means of a helium leak test.Based on the conducted investigations of the device being subject to this complaint, no manufacturing or material related root cause could be determined.The most probable root cause for the reported event is related to the patients anatomy.

• Brand Name: ORSIRO MISSION 2.75/22
• 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: 18241955
• MDR Text Key: 329452512
• Report Number: 1028232-2023-06067
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130441873
• UDI-Public: (01)07640130441873(17)2409
• 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: 01/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 419127
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 08223626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2022
• 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