MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO (US) 2.5/30; CORONARY DRUG-ELUTING STENT

Model Number	401766
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The orsiro drug-eluting stent system was selected for use.No pre-dilatation was conducted.During inflation the balloon of the orsiro stent system ruptured longitudinal at 16 to 18 bar.The stent remained deployed inside the patients body and the delivery system was removed.
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 orsiro revealed that the balloon was partly deflated and contained contrast medium and blood residues in the balloon lumen.An inflation device was connected and at a pressure of about 3-4 atm a jet of water was seen to emerge from the distal part of the balloon.A microscopic leakage was detected about 0.5 mm proximal to the distal xray marker.Further, microscopic analysis showed several deep scratches on the balloon surface near by 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 root cause is most likely related to the patients anatomy (severely calcified lesion).Furthermore it should be noted that, according to the ifu, pre-dilatation of the lesion is mandatory and rbp should not be exceeded.

• Brand Name: ORSIRO (US) 2.5/30
• 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: 8819687
• Report Number: 1028232-2019-03093
• Device Sequence Number: 3027238
• Product Code: NIQ
• UDI-Device Identifier: 07640130439214
• UDI-Public: 07640130439214
• 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: 11/28/2020
• Device Model Number: 401766
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 11183766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2019
• Initial Date Received by Manufacturer: 07/15/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 10/01/2019
• 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