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

Model Number	1145300-18
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Internal file number - (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 balloon material rupture was unable to be confirmed; however, there was noted inner member damage/leak.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 other incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that as the device was advanced over the guide wire interaction with the tip of the guide wire resulted in the noted tear in the inner member, thus as the compromised device was inflated resulted in the reported material rupture/noted inner member tear/leak.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
Event or Problem Description
It was reported that the patient underwent a coronary procedure to treat a target lesion in the mid left anterior descending artery.The 3.0 x 18 mm xience alpine stent delivery system was advanced to the target lesion and the balloon was inflated to nominal pressure to deploy the stent; however, a pinhole leak was suspected when they began to lose pressure on the inflation device.The balloon was inflated quickly and to higher pressure, but below rated burst pressure, in order to deploy the stent; however, a balloon rupture occurred.The stent was fully deployed and was well apposed to the vessel wall.There were no adverse patient effects and no clinically significant delay.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: 6683230
• Report Number: 2024168-2017-05588
• Device Sequence Number: 13695530
• Product Code: NIQ
• UDI-Device Identifier: 08717648200076
• UDI-Public: (01)08717648200076(17)200209(10)7020241
• 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
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/30/2017

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: 02/09/2020
• Device Model Number: 1145300-18
• Device Catalogue Number: 1145300-18
• Device Lot Number: 7020241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2017
• Initial Report FDA Received Date: 06/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1