MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 3.5/18; CORONARY DRUG-ELUTING STENT

Model Number	364491
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Combination product: yes.
Event or Problem Description
An orsiro drug eluting stent system was selected for treatment.The balloon did not inflate and the pressure did not rise.The orsiro was removed and the intervention was completed with and other device.
Additional Manufacturer Narrative
Combination product: yes.The returned device was subjected to a detailed technical analysis and the corresponding product release documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.The technical investigation revealed that the balloon shoulders are slightly unfolded, and blood was found inside of the inflation lumen and the balloon lumen.The stent is still crimped on the balloon between the x-ray markers and the crimped diameter is still in specification.The proximal balloon shoulder shows a damage in the shape of a small cut.This cut is reaching through the wall of the balloon shoulder, causing a leakage.The leakage of the balloon most likely contributed to the inability to expand the stent.However, the cause of the damage of the balloon shoulder could not be clarified.Review of the product release documentation verified that the instrument detailed above was manufactured according to specifications.The device 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 and a pressure test.The instrument was delivered in a leak-proof condition.Based on the conducted investigations no material or manufacturing related root cause could be identified.

• Brand Name: ORSIRO 3.5/18
• 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: 12166359
• Report Number: 1028232-2021-03968
• Device Sequence Number: 3705376
• Product Code: NIQ
• UDI-Device Identifier: 07640130439061
• UDI-Public: 7640130439061
• Combination Product (Y/N): Y
• 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,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2021

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: 10/16/2021
• Device Model Number: 364491
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 10190499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Initial Date Received by Manufacturer: 07/13/2021
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 08/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1