MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION 3.5/13; CORONARY DRUG-ELUTING STENT

Model Number 419111

Device Problem Material Puncture/Hole (1504)

Patient Problem Hematoma (1884)

Event Date 10/23/2023

Event Type  malfunction  

Event Description

An orsiro mission drug-eluting stent system was selected for treatment of a mildly calcified lesion (99 percent stenosis degree) in the mildly tortuous mid lad.After pre-cutting with a cutting balloon, the orsiro mission was placed at the lesion site with 10 atm.Post-dilation at 12 atm was attempted, but the balloon was not pressurized and ruptured.Confirmatory contrast imaging showed a hematoma caused by pinhole of the balloon.Subsequently a stent was placed in the distal area.

Manufacturer Narrative

Combination product: yes.

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 and the ivus recordings were reviewed.The technical investigation confirmed that the balloon has been inflated and was deflated in the as-returned state.Functional testing was performed by inflating the device with water during which a fine jet of water was seen to emerge from the proximal balloon portion.Microscopic inspection revealed a small pinhole in the balloon material 1 mm distal to the proximal radiopaque marker.Tiny scratches were observed in close vicinity to the pinhole which have likely been caused by a hard, sharp edged object such as e.G., anatomical structure.The angiographic films shows the treatment of the target lesion in the medial lad with a pre-dilation.During the positioning of the stent, during contrast injection, a dissection is already visible in the medial section of the stent.The implantation of the complaint stent is not visible.After implantation, a hematoma is visible proximal to the proximal stent portion.It cannot be clarified from the review of the angiographic materialt if the cutting balloon has caused the dissection along the target lesion, which was already present at the time of the stent positioning.Also, it cannot be clarified, if the hematoma is an injury caused by the reported balloon pinhole or if it was caused as a consequence of the already present dissection and has extended into the proximal end of the implanted stent.In the provided ivus recordings, the presence of a hematoma could be confirmed.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 product 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.We can therefore confirm that the product was delivered in a leak-proof condition.Based on the conducted investigations, no manufacturing or material related root cause could be determined.The root cause is most likely related to the patients anatomy.Please review the content of the draft report prior submitting it to fda and provide us a copy of the report as usual.

• Brand Name: ORSIRO MISSION 3.5/13
• 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: 18057836
• MDR Text Key: 327764661
• Report Number: 1028232-2023-05621
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130441712
• UDI-Public: (01)07640130441712(17)2404
• 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,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2024
• Device Model Number: 419111
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 03225754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2023
• Initial Date FDA Received: 11/02/2023
• Supplement Dates Manufacturer Received: 12/18/2023
• Supplement Dates FDA Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2022
• 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