MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 3.0/22; CORONARY DRUG-ELUTING STENT

Model Number 364502

Device Problem Difficult or Delayed Positioning (1157)

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

Event Date 01/14/2021

Event Type  malfunction  

Manufacturer Narrative

Combination product: yes.

Event Description

An orsiro drug-eluting stent system was selected for the treatment of a lesion in the lca.After successful stent deployment it was not possible to deflate the delivery balloon.After special maneuvers (replace two new indeflators, exchange the wire) the balloon was successfully deflated and the procedure could be continued.

Manufacturer Narrative

Combination product: yes.The returned instrument was subjected to a 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.The technical investigation revealed that the balloon has been inflated and was partially deflated in the as-returned state.A medium amount of dried contrast medium residue was observed in the balloon- and inflation lumen.The balloon could be inflated and deflated within the specified maximum deflation time.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.Based on the conducted investigations, no manufacturing or material related root cause could be determined.It should be noted that the ifu states that negative pressure should be applied to the balloon for at least 35 seconds.

• Brand Name: ORSIRO 3.0/22
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 11314492
• MDR Text Key: 231391476
• Report Number: 1028232-2021-00746
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• PMA/PMN Number: P170030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2022
• Device Model Number: 364502
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 03204825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Date Manufacturer Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1