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

Catalog Number	1125350-15
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Medical devices: dilatation catheter: chocolate (medtronic), guiding catheter: guideliner.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 identified no similar incidents from this lot.The investigation determined that the reported device damaged by another device appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.(b)(4).
Event or Problem Description
It was reported the procedure was performed to treat a heavily calcified tight lesion in the left anterior descending (lad) coronary artery.Several balloons were used to complete pre-dilatation because the lesion was very tight.The 3.5 x 15 mm xience alpine stent delivery system (sds) was advanced to the tightest part of the lesion and deployed successfully.The stent was fully apposed; however, further ballooning was required because the lesion was still tight just distal to the implanted stent due to the high calcium in the lesion.During removal of the balloon catheter and guideliner catheter, the implanted stent was explanted.The explanted stent was on the balloon catheter and all devices were removed together from the patients anatomy.Several balloon catheters were used in an attempt to cross the lesion a second time, but nothing crossed; therefore, the procedure was aborted.There was no adverse patient effect and no clinically significant delay in the procedure.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: 7520767
• Report Number: 2024168-2018-03665
• Device Sequence Number: 11122361
• Product Code: NIQ
• UDI-Device Identifier: 08717648199523
• UDI-Public: 08717648199523
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted 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): 05/16/2018

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: 02/18/2021
• Device Catalogue Number: 1125350-15
• Device Lot Number: 8013161
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2018
• Initial Report FDA Received Date: 05/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR