MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 2.25/22 CORONARY DRUG-ELUTING STENT

Model Number 364499

Device Problems Material Rupture (1546); Device Dislodged or Dislocated (2923)

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

Event Date 06/17/2021

Event Type  malfunction  

Manufacturer Narrative

Combination product: yes.

Event Description

An orsiro drug-eluting stent system was selected for treatment of a mildly calcified lesion (90 percent stenosis degree) in a mildly tortuous distal lad. After predilatation the device was advanced to the lesion. When the balloon was inflated with nominal pressure, the pressure did not rise and blood was also observed, so it was judged that the balloon was ruptured and the catheter was removed. During withdrawal the stent has dislodged and remained in the coronary artery as confirmed by angiography. Recovery by snare was considered, but since the stent had moved slightly to distal, it was adapted to the vessel wall. A guideplus extension catheter was used during procedure.

• Brand Name: ORSIRO 2.25/22
• 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: 12127096
• MDR Text Key: 260225482
• Report Number: 1028232-2021-03824
• Device Sequence Number: 1
• Product Code: NIQ
• 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: company representative,distri
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/06/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/27/2021
• Device Model Number: 364499
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 07195707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial