MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO (US) 2.75/40; CORONARY DRUG-ELUTING STENT

Model Number 404674

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 12/09/2021

Event Type  malfunction  

Event Description

An orsiro drug-eluting stent system was selected for treatment of a severely calcified lesion (90 percent stenosis degree) in a moderately tortuous proximal lad and an isr in the distal lad.After pre-dilatation an orsiro stent was successfully implantation in the proximal lad.The second orsiro 2.75/40 was selected to treat the distal isr but could not pass through the already implanted stent and it was decided to remove it for further balloon dilatations.Since the balloon could not pass it was decided that the lesion was too tight and the guidewire was removed.During the control angio it was noticed that the stent has been dislodged from the balloon by getting caught at the guiding catheter.The physician tried to remove the stent with a snare.The patient was sent to cv surgery.The patient was finally doing fine.

Manufacturer Narrative

Neither the complaint instrument nor the angiographic material was returned for analysis.Therefore, no technical investigation on the subject could be performed.The product release documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.One photograph taken from the angiogram was provided for analysis.The photograph with a rather poor quality shows a dislodged stent at the distal end of the guiding catheter up to the previously implanted stent whereas the stent appears severely deformed.Review of the product release documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.As a part of final inspection every stent system undergoes visual inspection to ensure correct embedding and homogeneous crimping of the stent.Further, the stent outer diameter and the stent retention force of a defined number of samples is tested from every lot.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be determined.The root cause for the complaint event is most likely related to the patients anatomy (i.E.Previously implanted stent).It should be noted that, according to the ifu, when treating multiple lesions, the distal lesion should be initially stented followed by stenting of the proximal lesion.In addition, during slow pull back of the stent system the user is advised to perform fluoroscopic control upon entry of the stent into the guiding catheter to avoid dislodgement of the stent from its position on the delivery system balloon.

• Brand Name: ORSIRO (US) 2.75/40
• 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: 13122155
• MDR Text Key: 283175484
• Report Number: 1028232-2021-06989
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130439436
• UDI-Public: 07640130439436
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P170030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2023
• Device Model Number: 404674
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 06216272
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2021
• 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): Required Intervention