MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND SYNSIRO PRO 2.5/22; CORONARY DRUG-ELUTING STENT

Model Number 419180

Device Problems Fluid/Blood Leak (1250); Material Deformation (2976)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 12/05/2023

Event Type  Injury  

Manufacturer Narrative

Combination product: yes.

Event Description

The synsiro pro drug-eluting stent system (complaint device) was selected for treatment of a severely calcified rca (stenosis degree 80 percent).After predilatation, the stent could be inserted into the target lesion but could not be deployed.The stent balloon could not be expanded further than 6 bar.An x-ray control showed contrast agent leakage into the vessel.The stent was removed from the patient with the delivery balloon.A stent strut of the removed stent stuck out.Afterwards, a second stent (reported separately) was used.Also, the second stent could be inserted into the target lesion but could not be deployed.The stent balloon could not be expanded further than 6 bar.An x-ray control showed again a contrast agent leakage into the vessel.This second stent was also removed from the patient with the delivery balloon.Again, a stent strut of the removed stent stuck out.Afterwards, a third synsiro pro stent could finally be implanted.Subsequently, the vessel was thrombosed because the applied heparin did not enter the bloodstream but ran under the skin.This resulted in vascular occlusion due to thrombi.The hospital stated that the synsiro pro des did not contribute to this final result.

Manufacturer Narrative

Combination product: yes.25-jan-2024 updated event description: the synsiro pro drug-eluting stent system (complaint device) was selected for treatment of a severely calcified lesion (80 percent stenosis degree) in a moderately tortuous segment of the medial to distal rca.After pre-dilatation, the stent was inserted into the target lesion but could not be deployed.The stent balloon could not be expanded further than 6 bar.An x-ray control showed contrast agent leakage into the vessel.The stent was removed from the patient with the delivery balloon.A stent strut of the removed stent stuck out.Afterwards, a second stent (reported under 1028232-2023-06358) was used.Also, the second stent was inserted into the target lesion but could not be deployed.The stent balloon could not be expanded further than 6 bar.An x-ray control showed a contrast agent leakage into the vessel.This second stent was also removed from the patient with the delivery balloon.Again, a stent strut of the removed stent stuck out.Subsequently, a third synsiro pro stent could successfully be implanted.After the treatment of the distal rca, the medial rca was treated with five synsiro pro stents overall.During the treatment, a thrombus was detected in the medial rca resulting in a closure of the vessel (reported under 1028232-2023-06360).An aspiration catheter was used to aspirate the thrombus.After the distal blood flow could not be improved any further, it was decided to stop the intervention and to treat the patient medically.The hospital stated that the venous catheter, through which the patient was dosed with heparin during the intervention, was not properly positioned in the vessel and an unspecified amount of heparin ended up underneath the patients skin instead of inside of the blood vessel.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 the reported event.In addition, the angiographic material provided was reviewed.The affected device was returned without its packaging.The balloon is well folded but shows signs of an inflation attempt (i.E., contrast medium residue in the balloon- and inflation lumen).Microscopic inspection of the balloon surface showed a longitudinal cut/tear with a length of about 1 mm above the distal radiopaque marker.In addition, a long scratch was observed from the tip towards the tear which implies that the damage in the balloon surface was most likely caused by a hard, sharp-edged object such as e.G., anatomical structure.Moreover, the stent is deformed at its proximal end (i.E., two struts are bent outwards and are everted).Stent imprints on the exposed balloon surface indicate that the bent struts were initially crimped on the balloon.Outside of the deformed zone the crimped diameter of the stent complies with the specification.Review of the angiographic material did not lead to any further information regarding the nature of the complaint.The actual complaint event (the stent deformation or the balloon leakage) is not visible.Review of the production documentation confirmed that the device was manufactured according to specifications and passed all in-process and final inspections.During final inspection, every stent system undergoes visual inspection to ensure correct stent embedding and homogeneous crimping of the stent.In addition to visual inspections each product is tested for air tightness by means of a helium leak test.We can therefore confirm that the product was delivered in a leak-proof condition.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 is most likely related to the patients anatomy.

• Brand Name: SYNSIRO PRO 2.5/22
• 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: 18357731
• MDR Text Key: 330898747
• Report Number: 1028232-2023-06402
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130442405
• UDI-Public: (01)07640130442405(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: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 419180
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 05231115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2023
• 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
• Patient Outcome(s): Required Intervention