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

Catalog Number	1125350-23
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/26/2017
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.Concomitant medical products: guide wire: balance middle weight universal i 190 cm.Guide catheter: medtronic ebu 6 french 3.5 launcher.Evaluation summary: the device was returned for analysis.The reported material deformation was able to be confirmed.The reported failure to advance was unable to be replicated in a testing environment as it was based on operational circumstances.The reported difficulty to remove was unable to be replicated in a testing environment due to the condition of the returned device.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 investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that as the sds was advanced resistance was met with the heavily calcified and moderately tortuous anatomy resulting in the reported failure to advance.During removal, interaction with the 6 french guide catheter resulted in the reported flared stutss; thus, resulting in the reported difficulty to remove.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 access site was the radial artery.During the heavily calcified, moderately tortuous left anterior descending coronary artery stenting procedure, the 3.5 x 23 mm xience alpine stent delivery system (sds) was unable to cross the lesion.During removal of the sds, the proximal stent struts were noted to be flared and the stent became stuck in the 6 french guide catheter.The guide catheter, sds and guide-wire were removed together as a unit.Additional predilatation was performed and three xience stents were successfully implanted.There was no adverse patient sequela or a 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: 6805421
• Report Number: 2024168-2017-06803
• Device Sequence Number: 985067
• Product Code: NIQ
• UDI-Device Identifier: 08717648199547
• UDI-Public: 08717648199547
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/18/2017

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: 03/23/2020
• Device Catalogue Number: 1125350-23
• Device Lot Number: 7031541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2017
• Initial Report FDA Received Date: 08/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 84