MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Model Number	1550275-18
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was discarded and will not return.Investigation is not complete.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the this was a percutaneous coronary intervention treating the left anterior descending (lad), heavily calcified lesion.Following pre-dilatation per ifu, a 2.75x18mm xience sierra stent delivery system (sds) advanced without any unusual resistance to the lesion site.During stent deployment, the xience sierra delivery balloon burst at 10 atmospheres.The delivery system was removed without issue and as additional treatment, a dilatation catheter advanced, dilating the stent.The stent was fully apposed at the intended lesion site.There was no adverse patient sequela and there was no clinically significant delay reported.No additional information was provided regarding this issue.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no similar incidents.The investigation determined that the reported balloon rupture was likely related to circumstances of the procedure.It is likely that the balloon interacted with the patient anatomy described as heavily calcified upon inflation attempt, such that it became damaged and ruptured as a result.A cause for the reported patient effect of additional treatment is subsequent to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9832161
• Report Number: 2024168-2020-02425
• Device Sequence Number: 727670
• Product Code: NIQ
• UDI-Device Identifier: 08717648227189
• UDI-Public: 08717648227189
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/25/2020
• Device Model Number: 1550275-18
• Device Catalogue Number: 1550275-18
• Device Lot Number: 9031541
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/20/2020
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 03/13/2020
• Supplement Report FDA Received Date: 04/02/2020
• 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: Required Intervention
• Patient Age: 70 YR