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

Catalog Number	1125300-23
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/27/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was not returned 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 did not indicate a lot specific quality issue.The xience alpine, (b)(4), instructions for use (ifu) is written in (b)(4); therefore the domestic xience alpine instructions for use (ifu) is referenced.The xience alpine everolimus eluting coronary stent system (eecss), domestic electronic instructions for use (ifu) states: if removal of a stent system is required prior to deployment, ensure that the guiding catheter is coaxially positioned relative to the stent delivery system, and cautiously withdraw the stent delivery system into the guiding catheter.Should unusual resistance be felt at any time when withdrawing the stent towards the guiding catheter, the stent delivery system and the guiding catheter should be removed as a single unit.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that after pre-dilating a heavily calcified lesion in the heavily tortuous proximal left anterior descending (lad) coronary artery, a 3.0x23mm rx xience alpine stent delivery system (sds) was advanced toward the target lesion, but was unable to cross due to patient anatomy.In order to perform additional pre-dilatation, the sds was withdrawn, but resistance was felt between the sds and an unspecified guiding catheter.Upon completing withdrawal against resistance, flared struts were noted on the proximal edge of the xience alpine stent.No other device issues were noted.A non-abbott sds was used successfully with the same guiding catheter and was used in successfully completing the procedure.There were no adverse patient effects and no occurrence of a clinically significant delay.No additional information was provided.

• Brand Name: XIENCE ALPINE 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: 6108139
• Report Number: 2024168-2016-08020
• Device Sequence Number: 10853618
• Product Code: NIQ
• UDI-Device Identifier: 08717648199363
• UDI-Public: (01)08717648199363(17)190706(10)6062141
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/16/2016

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: 07/06/2019
• Device Catalogue Number: 1125300-23
• Device Lot Number: 6062141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2016
• Initial Report FDA Received Date: 11/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1