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

Model Number	1550400-12
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number e2019001.The device was received.Investigation is not complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2019, a percutaneous coronary intervention was performed on the mid right coronary artery (rca) lesion.A 4.0x12mm xience sierra stent was directly implanted in the mildly calcified mid rca.Using the xience sierra dilatation balloon, dilatation was performed at 12 atmospheres for 15 seconds and then 16 atms for 25 seconds.During that second inflation, the balloon had ruptured.The delivery system was removed without resistance and another balloon catheter was used to perform additional dilatation.The stent remained fully apposed to the mid rca site.There was no adverse patient sequela and there was no clinically significant delay.No additional information was provided regarding this issue.
Additional Manufacturer Narrative
The device was returned for analysis.The reported material rupture was confirmed.A review of the lot history record identified a manufacturing nonconformity issued to the reported lot that contributed to this event.Additionally, a review of the complaint history indicated a lot specific quality issue.The investigation determined the reported material rupture appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

• 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: 9598306
• Report Number: 2024168-2020-00748
• Device Sequence Number: 16775598
• Product Code: NIQ
• UDI-Device Identifier: 08717648227486
• UDI-Public: 08717648227486
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2020

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: 03/09/2021
• Device Model Number: 1550400-12
• Device Catalogue Number: 1550400-12
• Device Lot Number: 8022641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Initial Date Received by Manufacturer: 12/23/2019
• Supplement Date Received by Manufacturer: 04/03/2020
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 04/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RUNTHROUGH GUIDE WIRE
• Outcome Attributed to Adverse Event: Required Intervention