MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number	1550225-12
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The product was not returned to abbott vascular for analysis.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 similar incidents from this lot.It should be noted that the xience sierra everolimus eluting coronary stent system instructions for use (ifu) states: contrast diluted 1:1 with heparinized normal saline.Deflate the balloon by pulling a negative on the inflation device.Large and longer balloons will take more time (up to 30 seconds) to deflate than smaller and shorter balloons.Confirm balloon deflation under fluoroscopy and wait 10-15 seconds longer.In this case, the ifu violations likely contributed to the reported difficulties of partial deflation issue and the difficulty to remove post deployment.The investigation determined the reported deflation issue and difficulty to remove post deployment appear to be related to the user error as 100% contrast was used in the procedure and not enough time was given for the device to deflate before retraction.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 moderately tortuous proximal left anterior descending artery.A 2.25 x 12 mm xience sierra stent was implanted and did not meet any resistance during advancement.The stent delivery system (sds) was inflated once at 15 atmospheres.However, the stent delivery balloon became stuck with the deployed stent during removal.It was reported that the balloon was deflated for 2-3 seconds.Therefore, more negative pressure was applied and the balloon was removed fully deflated.Additionally, slight force was used to remove the sds from the anatomy to successfully complete the procedure.The stent was fully apposed to the lesion.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7613893
• Report Number: 2024168-2018-04591
• Device Sequence Number: 205085
• Product Code: NIQ
• UDI-Device Identifier: 08717648227004
• UDI-Public: 08717648227004
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/19/2018

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: 04/24/2019
• Device Catalogue Number: 1550225-12
• Device Lot Number: 8041141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 06/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1