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

Catalog Number	1145250-08
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2018
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.Evaluation summary: the device was returned for analysis.The reported material deformation (flared stent) was confirmed.The reported difficulty to remove could not be confirmed due to the condition the device was returned and the reported failure to advance could not be replicated in a testing environment as it is related to operational context of the procedure.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 the device interacted with the patient anatomy causing the reported failure to advance and subsequent distal end ring flaring.The device was then removed but met resistance likely due to the reported end ring flaring causing 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 procedure was to treat a de novo lesion in the left proximal anterior descending coronary artery with moderate tortuosity and moderate calcification.A 2.50 x 8 mm xience alpine stent delivery system (sds) was advanced but failed to cross the lesion due to the patient anatomy.On removal of the sds without force, the stent met resistance of an unknown cause.Outside of the patient anatomy, the stent struts were noted to be flared.There was no damage to the balloon.The procedure was successfully completed with an additional 2.50 x 8 mm xience alpine sds.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: XIENCE ALPINE OTW 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: 7770125
• Report Number: 2024168-2018-06146
• Device Sequence Number: 16659541
• Product Code: NIQ
• UDI-Device Identifier: 08717648199868
• UDI-Public: 08717648199868
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/09/2018

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: 08/07/2019
• Device Catalogue Number: 1145250-08
• Device Lot Number: 6072841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2018
• Initial Report FDA Received Date: 08/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 99