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

Model Number	1550350-15
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Ventricular Fibrillation (2130)
Date of Event	01/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned for analysis.The reported inflation and deflation issues were not confirmed as the balloon inflated without anomalies and deflated flat within the specified times x3.The wall apposition issue was based on operational context and could not be confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.The reported patient effect of ventricular fibrillation is listed in the xience sierra everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.The investigation was unable to determine a conclusive cause for the reported deflation issue as no issue was identified during return device analysis.The reported inflation and wall apposition issues appear to be related to operational context of the procedure.Additionally, the reported patient effect of ventricular fibrillation appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was to treat a de novo lesion located in the proximal left anterior descending coronary artery that was non-calcified, non-tortuous and 90% stenosed.The xience sierra stent system was advanced to the lesion without issues and inflated twice to 12 atmospheres for 10 seconds.It was noted that the wall apposition of the proximal part of the stent was not sufficient, due to how the balloon was inflating, so the delivery system was pulled back about 1 mm and inflated to 14 atmospheres.Attempts to deflate the balloon were made, but it failed to deflate.The patient condition was getting worse and ventricular fibrillation was observed, so the xience sierra stent delivery system was removed slowly.At this point it was noted that the balloon was appearing to deflate.The system was successfully removed and post dilatation was performed for complete wall apposition of the stent.No other treatment was given to the patient.No additional information was provided.

• Brand Name: XIENCE SIERRA
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9741618
• Report Number: 2024168-2020-01701
• Device Sequence Number: 2483423
• Product Code: NIQ
• UDI-Device Identifier: 08717648227417
• UDI-Public: 08717648227417
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/21/2020

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: 09/09/2021
• Device Model Number: 1550350-15
• Device Catalogue Number: 1550350-15
• Device Lot Number: 809034A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 02/21/2020
• 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