• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 4.0/35 CORONARY DRUG-ELUTING STENT Back to Search Results
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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameORSIRO 4.0/35
Type of DeviceCORONARY 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 Key10613612
MDR Text Key209393721
Report Number1028232-2020-04210
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberP170030
Number of Events Reported1
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
0 PatientS WERE Involved in the Event:
Date FDA Received10/01/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/06/2021
Device MODEL Number391019
Device Catalogue NumberSEE MODEL NO.
Device LOT Number05193911
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/30/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/07/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-