MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION 3.0/15; CORONARY DRUG-ELUTING STENT

Model Number 419116

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/05/2022

Event Type  malfunction  

Manufacturer Narrative

Combination product: yes.

Event Description

During treatment of a total occlusion with thrombus aspiration and a competitors balloon, the balloon ruptured.Subsequently, the orsiro mission drug-eluting stent system was inserted, but it could not be expanded at all.So the delivery catheter was removed from the body.Outside the body, a leakage of the balloon was confirmed.Another stent was used to complete the intervention.

Manufacturer Narrative

Combination product: yes.The returned device was subjected to a detailed technical analysis and the corresponding product release documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.The technical investigation revealed that the balloon is still well folded.Contrast medium was found inside of the inflation lumen and the balloon lumen.The stent is still crimped on the balloon between the x-ray markers and the crimped diameter is still in specification.The distal balloon shoulder shows a damage in the shape of a small cut in diagonal direction.This cut is reaching through the wall of the balloon shoulder, causing a leakage.The leakage of the balloon most likely contributed to the inability to expand the stent.However, the cause of the damage of the balloon shoulder could not be clarified.Review of the product release documentation verified that the instrument detailed above was manufactured according to specifications.The device fulfilled all the requirements of in-process and final inspection.In addition to visual inspections each instrument is tested for air tightness by means of a pressure test and a helium leak test.The instrument was delivered in a leak-proof condition.Based on the conducted investigations no material or manufacturing related root cause could be identified.

• Brand Name: ORSIRO MISSION 3.0/15
• 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: 16019921
• MDR Text Key: 306019058
• Report Number: 1028232-2022-06553
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130441767
• UDI-Public: (01)07640130441767(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: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 419116
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 03226077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2022
• 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