MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 3.5/35; CORONARY DRUG-ELUTING STENT

Model Number 391018

Device Problem Deflation Problem (1149)

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

Event Date 03/16/2021

Event Type  malfunction  

Manufacturer Narrative

Combination product: yes.

Event Description

An orsiro drug-eluting stent system was selected for treatment of a pre-dilated lesion (75 percent stenosis degree) in the rca.After stent implantation it was noticed that the deflation time was longer than usual (more than 15 seconds, normally 10 seconds).

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 inflation device used in the intervention was returned and identified as a medtronic everest 30.The technical investigation revealed that the balloon has been inflated and was deflated in the as-returned state.A small amount of contrast medium residue was observed in the balloon- and inflation lumen.The balloon could be inflated and deflated within the specified maximum deflation time with the returned inflation device medtronic everest 30.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.The root cause for the reported event is most likely related to the handling during the procedure (i.E.Insufficient deflation time).It should be noted that the ifu advises the user that the instrument shall be deflated for at least 35 seconds.

• Brand Name: ORSIRO 3.5/35
• 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: 11633475
• MDR Text Key: 244392979
• Report Number: 1028232-2021-01661
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130439399
• UDI-Public: 07640130439399
• 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: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/17/2022
• Device Model Number: 391018
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 03204787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Date Manufacturer Received: 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1