MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO (US) 2.5/22; CORONARY DRUG-ELUTING STENT

Model Number	401754
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The orsiro drug-eluting stent system was selected for use.After successful lesion crossing it was not possible to inflate the balloon of the orsiro stent system.Therefore the device was removed from the patients body and the procedure was finished with another device.
Additional Manufacturer Narrative
The returned device 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 this event.During the technical investigation a leakage in the proximal part of the balloon was detected.Microscopic inspection revealed a 1 mm long tear in the balloon over the proximal x-ray marker.Review of the production documentation of the product detailed above verified that the instrument was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.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 manufacturing or material related root cause was determined.

• Brand Name: ORSIRO (US) 2.5/22
• 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: 8819688
• Report Number: 1028232-2019-03092
• Device Sequence Number: 2348500
• Product Code: NIQ
• UDI-Device Identifier: 07640130439092
• UDI-Public: 07640130439092
• 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): 07/15/2019

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: 10/07/2020
• Device Model Number: 401754
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 09183614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Initial Date Received by Manufacturer: 07/22/2019
• Supplement Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 09/25/2019
• 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