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

Catalog Number	1125250-38
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/08/2018
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 rupture was unable to be confirmed.It was noted that the guide wire exit notch was torn distally.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 was unable to determine a conclusive cause for the reported material rupture as no rupture was noted during returned device analysis.It is likely however, that the noted torn material was incorrectly identified as a material rupture.The investigation determined the noted torn material was likely due to operational context of the procedure as it is likely manipulation of the device and/or interaction with other devices while advancing the device to the moderately tortuous and heavily calcified lesion caused the noted torn material.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported the procedure was to treat a moderately tortuous and heavily calcified lesion in the mid left anterior descending (lad) artery.The lesion was pre-dilated with a non-abbott balloon catheter.The 2.50x38mm xience alpine stent delivery system (sds) was advanced to the lesion with no resistance.During attempted inflation, the balloon would not hold pressure and a rupture was suspected.The sds was removed with the stent still intact on the balloon.Another 2.50x38mm xience alpine sds was advanced however failed to cross due to the anatomy.The procedure was completed with two non-abbott stents.There was no clinically significant delay in the procedure and no adverse patient effects.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: 7534371
• Report Number: 2024168-2018-03810
• Device Sequence Number: 2512859
• Product Code: NIQ
• UDI-Device Identifier: 08717648199219
• UDI-Public: 08717648199219
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 05/22/2018

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: 08/01/2020
• Device Catalogue Number: 1125250-38
• Device Lot Number: 7072141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 05/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 61