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

Model Number 364482

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/24/2019

Event Type  malfunction  

Event Description

Ous mdr - after pre-treatment of the calcified lesion using a cutting balloon, an orsiro drug-eluting stent system was chosen for further treatment.The device was delivered, crossed the lesion and was inflated.During inflation the pressure appeared to decrease and the physician decided to remove the device from patient body.After withdrawal leaking from the proximal balloon shoulder was observed.

Manufacturer Narrative

The returned delivery system 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 device revealed during functional testing a fine jet of water in the cylindrical balloon part about 2 mm distal to the proximal x-ray marker.The microscopic analysis of the balloon surface showed a microscopic leakage and scratches on the balloon surface nearby the damage site.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 of the balloon surface is most likely related to the patients anatomy.

• Brand Name: ORSIRO 2.5/15
• Type of Device: CORONARY DRUG-ELUTING STENT SYSTEM
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 8592693
• MDR Text Key: 144474611
• Report Number: 1028232-2019-01878
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P170030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2020
• Device Model Number: 364482
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 03184130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Date Manufacturer Received: 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1