MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 2.5/26; CORONARY DRUG-ELUTING STENT

Model Number	364506
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
An orsiro drug-eluting stent was chosen to treat a calcified lesion in the proximal cx.During inflation the balloon ruptured.
Additional Manufacturer Narrative
The returned instrument was subjected to a 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 device shaft is severely elongated as well as kinked and twisted at the skive.The usable length of the device does not comply anymore with the specification, indicating application of a high tensile force.The two xray markers have shifted in distal direction and are located directly proximal to the distal tip weld.The balloon has been inflated, burst longitudinally and transversally and has eventually fractured.The proximal balloon fragment has a length of about 9 mm.Microscopic inspection revealed several scratches on the balloon surface.The distal balloon fragment was not returned for analysis.It was confirmed that no device parts remained inside the patients body.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.Based on the conducted investigations no material or manufacturing related root cause could be identified.The root cause for the balloon burst is most likely related to the patients anatomy (i.E.Moderately severely calcified lesion).The severe elongation of the device shaft and the balloon fracture most likely occurred due to a mechanical overload during withdrawal.

• Brand Name: ORSIRO 2.5/26
• 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: 9167845
• Report Number: 1028232-2019-04359
• Device Sequence Number: 14146829
• Product Code: NIQ
• UDI-Device Identifier: 07640130439153
• UDI-Public: 7640130439153
• 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): 10/07/2019

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: 01/17/2021
• Device Model Number: 364506
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 12183634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 12/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1