MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION 2.75/30; CORONARY DRUG-ELUTING STENT

Model Number 419139

Device Problems Material Puncture/Hole (1504); Failure to Unfold or Unwrap (1669); Device Dislodged or Dislocated (2923)

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

Event Date 01/31/2024

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 in the mildly tortuous part in the proximal to mid lad.During the intervention, it was difficult to push the stent system once it was inserted into the guiding catheter.The location of the lesion was reached, but the balloon of the delivery system was unable to completely expand.The wire was stuck with the stent system and was withdrawn from the patient.

Manufacturer Narrative

Combination product: yes (b)(6) 2024 the device was inflated with 10 atm but the stent could not be completely expanded.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.In the as-returned state, the affected device was located inside a 6f terumo jl 4.0 guiding catheter with about 305 mm of the device protruding from the distal end of the guiding catheter.The guiding catheter was undamaged besides a few mild kinks in its distal portion.The balloon shoulders of the affected device were slightly unfolded.The stent was slightly opened at its distal end and severely deformed at its proximal end, i.E.Several struts were strongly bent.Judging from the xray markers, the stent was also displaced on the balloon by about 4 mm in distal direction.Stent imprints were observed on the exposed balloon surface, indicating that the stent was crimped in between the two radiopaque markers at the time of delivery.During functional testing, a fine jet of water was seen to emerge from the distal balloon portion.Microscopic inspection revealed a pinhole at the distal radiopaque marker.The pinhole followed a deep longitudinal scratch in the balloon surface which has likely been caused by a hard, sharp-edged object such as e.G., anatomical structure.The 0.014 inch guidewire used in the intervention was located in the guidewire lumen of the affected device.During the investigation, the guidewire could be removed and reintroduced with no unusual friction.The angiographic material shows the treatment of both the lad and lcx during which an incomplete inflation of a stent can be seen.However, review of the angiographic material did not provide further relevant information regarding the root cause of the reported event.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 2.75/30
• 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: 18890274
• MDR Text Key: 337552763
• Report Number: 1028232-2024-01375
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130441996
• UDI-Public: (01)07640130441996(17)2506
• 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: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 419139
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 05234380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2023
• 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