MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 4.0/35; CORONARY DRUG-ELUTING STENT

Model Number 391019

Device Problem Fracture (1260)

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

Event Date 02/21/2020

Event Type  malfunction  

Manufacturer Narrative

Combination product: yes.

Event Description

An orsiro drug-eluting stent system was selected for treatment of a lesion (80 percent stenosis degree) in the rca.During the attempt to cross the lesion a fracture at the proximal shaft of the stent system has occurred.It was stated that after removal it was noticed that the stent was also fractured.

Manufacturer Narrative

Combination product: yes the returned instrument 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 technical investigation of the returned device revealed that the hypotube has fractured about 14cm distal to the distal end of the kink protector.Several small kinks were observed in the hypotube.The cross section of the hypotube is no longer circular but compressed and the polymer coating is plastically deformed.The findings indicate that the hypotube was most probably significantly bent outside of the patients body and eventually fractured during the lesion crossing attempt.Moreover, the stent is displaced by 7.5mm distally, but the balloon is still well folded and shows no signs of inflation.Stent imprints on the exposed balloon surface indicate that the stent was initially crimped in between the two radiopaque markers.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all in process and final inspections.During final inspection and inner packaging every device is visually inspected for kinks.As a part of final inspection every stent system also undergoes visual inspection to ensure correct embedding and homogeneous crimping of the stent.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, no manufacturing or material related root cause could be determined.

• Brand Name: ORSIRO 4.0/35
• 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: 10613612
• MDR Text Key: 209393721
• Report Number: 1028232-2020-04210
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/06/2021
• Device Model Number: 391019
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 05193911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2019
• 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