MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO (US) 3.0/15; CORONARY DRUG-ELUTING STENT

Model Number	401744
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
An orsiro drug-eluting stent system was chosen for treatment of a calcified lesion in the distal rca.After placing the stent in the target lesion, the balloon could not be inflated.
Additional Manufacturer Narrative
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.The technical investigation of the returned product revealed that both balloon shoulders and both ends of the stent are slightly opened.The stent is severely deformed at its proximal end and displaced by about 1 mm in distal direction.Microscopic inspection of the guidewire exit port revealed that both the guidewire lumen and the inflation lumen are sliced open longitudinally.During functional testing water was found leaking from the guidewire exit port.The balloon could not be inflated.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.In addition to visual inspections each instrument is tested for air tightness by means of a helium leak test.We can therefore confirm that the instrument was delivered in a leak-proof condition.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be determined.The damage at the guidewire exit port was most likely caused during the preparations for the intervention or during the insertion phase.The displacement and severe deformation at the proximal end of the stent most likely happened after the actual complaint event (e.G.During withdrawal back into the guiding catheter).

• Brand Name: ORSIRO (US) 3.0/15
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 9662497
• Report Number: 1028232-2020-00550
• Device Sequence Number: 16268875
• Product Code: NIQ
• UDI-Device Identifier: 07640130438996
• UDI-Public: 07640130438996
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P170030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/26/2021
• Device Model Number: 401744
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 06191510
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/20/2020
• Supplement Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 02/03/2020
• Supplement Report FDA Received Date: 04/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1