MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO (US) 2.5/15; CORONARY DRUG-ELUTING STENT

Model Number	401742
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Death (1802)
Date of Event	01/10/2020
Type of Reportable Event	Death
Event or Problem Description
An orsiro drug-eluting stent system was selected to treat a severely calcified lesion (100 percent stenosis degree) in a mildly tortuous lad.After pre-dilatation the device was placed in the target lesion but could not be fully inflated.After withdrawal, the stent was still on the balloon.Patient finally passed away.According to the information from the hospital patient was a stemi.The death was reported as not device related.
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 instrument revealed that the balloon shows signs of inflation and is slightly unfolded at both ends.The stent is severely deformed at its proximal end and displaced on the balloon by about 2 mm in proximal direction.During the investigation the complaint instrument could be inflated to 7 atm (np), be held at this pressure and deflated again without any apparent irregularity.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.

• Brand Name: ORSIRO (US) 2.5/15
• 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: 9639208
• Report Number: 1028232-2020-00410
• Device Sequence Number: 16841944
• Product Code: NIQ
• UDI-Device Identifier: 07640130438972
• UDI-Public: 07640130438972
• 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): 01/16/2020

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: 06/27/2021
• Device Model Number: 401742
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 06190862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 01/28/2020
• Supplement Report FDA Received Date: 04/29/2020
• 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: Death
• Patient Age: 61 YR