MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 3.5/26; CORONARY DRUG-ELUTING STENT

Model Number 364509

Device Problems Deflation Problem (1149); Device Dislodged or Dislocated (2923)

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

Event Date 10/01/2021

Event Type  malfunction  

Event Description

An orsiro drug eluting stent system was selected for treatment of a lesion in the mild calcified lad.During the attempt to inflate the delivery balloon it was detected that the stent has been dislodged inside the protector cap.Furthermore it was noticed that the deflation time was longer than usual.

Manufacturer Narrative

The returned instrument 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 the reported event.The technical investigation revealed that the balloon has been inflated and was deflated in the as returned state.Contrast medium residue was observed in the balloon and inflation lumen.Microscopic inspection of the balloon surface revealed stent imprints, indicating that the stent was properly crimped in between the two radiopaque markers at the time of delivery.The stent was returned on the transportation wire and located at the proximal end of the stent protector.The stent is severely deformed (i.E.Flat) over its entire length.During the investigation the balloon could be inflated and deflated according to the instructions for use.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 is verified to 100 percent and the stent retention force of a defined amount 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 was determined.It should be noted that the ifu advises the user to visually inspect the stent system prior to the procedure and not to use if any defects are noted.

• Brand Name: ORSIRO 3.5/26
• 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: 12721054
• MDR Text Key: 279081178
• Report Number: 1028232-2021-05922
• Device Sequence Number: 1
• Product Code: NIQ
• 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: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/21/2023
• Device Model Number: 364509
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 03214838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2021
• 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