MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 2.75/26; CORONARY DRUG-ELUTING STENT

Model Number	364507
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/24/2019
Type of Reportable Event	Malfunction
Event or Problem Description
An orsiro drug-eluting stent system was chosen to treat a calcified lesion (99 percent stenosis degree) in the rca.It was not possible to inflate the delivery balloon of the orsiro stent system.
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.Further, the provided angiographic material was reviewed.The technical investigation of the returned instrument revealed that the balloon was well folded, but contained contrast medium residue in the balloon lumen and showed signs of an inflation attempt.The stent is positioned well between the x-ray markers and slightly opened at its proximal end.Upon inflation a fine jet of water was seen to emerge from the proximal part of the balloon.Microscopic inspection revealed a small tear in the balloon surface, located at the distal end of the proximal xray marker.The proximal x-ray marker was found deformed at its distal end.Review of the angiographic material did not lead to any further information regarding the nature of the complaint.The actual complaint event is not visible in the provided angiographic material.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, no manufacturing or material related root cause could be determined.The damage pattern indicates a mechanical load that was applied to the instrument which lead to both the deformation of the x-ray marker and the damage of the balloon.

• Brand Name: ORSIRO 2.75/26
• 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: 9401966
• Report Number: 1028232-2019-05325
• Device Sequence Number: 2166875
• Product Code: NIQ
• UDI-Device Identifier: 07640130439160
• UDI-Public: 07640130439160
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P170030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2019

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: 03/12/2021
• Device Model Number: 364507
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 02195564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 02/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization