MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO (US) 3.5/15; CORONARY DRUG-ELUTING STENT

Model Number 401745

Device Problem Deflation Problem (1149)

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

Event Date 05/26/2021

Event Type  malfunction  

Manufacturer Narrative

Combination product: yes.

Event Description

An orsiro drug-eluting stent system was selected for treatment.After stent deployment the balloon would not fully deflate.It took multiple attempts to finally get the balloon down to remove through the catheter.

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.The balloon was deflated in the as-returned state, but dried contrast medium residue was observed in the balloon- and inflation lumen.The hypotube shows several mild kinks which may have contributed to the complaint event.Microscopic inspection of the instrument revealed no other damage or irregularity.Functional testing was successfully performed, i.E.The balloon could be inflated and fully deflated.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.

• Brand Name: ORSIRO (US) 3.5/15
• 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: 12016505
• MDR Text Key: 256718934
• Report Number: 1028232-2021-03422
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130439009
• UDI-Public: 07640130439009
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2022
• Device Model Number: 401745
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 08202856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• Initial Date Manufacturer Received: 06/02/2021
• Initial Date FDA Received: 06/17/2021
• Supplement Dates Manufacturer Received: 08/06/2021
• Supplement Dates FDA Received: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization