MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 4.0/18; CORONARY DRUG-ELUTING STENT

Model Number	364492
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/24/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Ous mdr - during inflation the balloon of the orsiro drug-eluting stent system ruptured at 20 bar.
Additional Manufacturer Narrative
The device was not returned to biotronik, no angiographic material was provided, no information on vascular morphology was obtained.Therefore no technical investigation on the subject could be performed.The manufacturing history was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.Review of the production documentation verified that the instrument was manufactured according to specifications and fulfilled all the requirements of 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 manufacturing or material related root cause could be determined.The final root cause for the leakage is most likely related to external factors during the procedure.However, it should be noted that the ifu strictly warns of exceeding rbp (16 atm).

• Brand Name: ORSIRO 4.0/18
• 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: 8520868
• Report Number: 1028232-2019-01534
• Device Sequence Number: 1846403
• Product Code: NIQ
• UDI-Device Identifier: 07640130439078
• UDI-Public: 07640130439078
• 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): 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/25/2020
• Device Model Number: 364492
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 11181689
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/12/2019
• Supplement Date Received by Manufacturer: 05/24/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 05/27/2019
• 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: Required Intervention