MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 2.75/35; CORONARY DRUG-ELUTING STENT

Model Number 391236

Device Problem Unintended Movement (3026)

Patient Problem Vascular Dissection (3160)

Event Date 10/26/2023

Event Type  Injury  

Manufacturer Narrative

Combination product: yes.

Event Description

The orsiro drug eluting stent was implanted in a pre-dilated moderately calcified lesion in proximal to mid lad with inflation up to 18 bar.During the rewiring of the jailed runthrough from d2, the stent migrated proximally in lad and was further extracted with entanglement of both guidewires into the catheter.It was retrieved with extraction of the whole system, catheter, guidewires and the stent.A dissection of proximal lad and distal lm was detected.Worsening of the systolic function of left ventricle after the dissection, and therefore immediate stenting of lm and lad was necessary.

Manufacturer Narrative

Combination product: yes.Only the stent was returned and subjected to a detailed technical analysis.The production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.In addition, the provided videos were reviewed.In the as-returned state the stent was entangled with the two guide wires as reported.The two guidewires have been cut before return shipment.The stent is severely deformed (i.E., elongated and stretched) over its entire length.The delivery system was not returned for analysis.Review of the provided videos confirmed the jailed guide wire in the d2.However, neither the complaint event nor the retrieval of the deformed stent is visible.The angiographic material does therefore not provide further relevant information regarding the root cause of the complaint.Review of the production 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 was identified.Considering the event description given by the physician, the most probable root cause for the complaint event is related to the handling (i.E., the guidewire got hooked with the implanted stent).The ifu clearly states to exercise care when crossing a newly deployed stent with a coronary guidewire to avoid disrupting the stent placement, apposition, coating, or stent geometry of the orsiro sirolimus eluting coronary stent.Further it should be noted that the ifu warns not to exceed the labeled rated burst pressure.

• Brand Name: ORSIRO 2.75/35
• 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: 18152406
• MDR Text Key: 328316428
• Report Number: 1028232-2023-05855
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130436855
• UDI-Public: (01)07640130436855(17)2503
• 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: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 391236
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 03230875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2023
• Initial Date FDA Received: 11/16/2023
• Supplement Dates Manufacturer Received: 12/15/2023
• Supplement Dates FDA Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2023
• 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