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

Catalog Number	1125300-28
Health Effect - Clinical Codes	Angina (1710); Perforation (2001)
Date of Event	08/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.It should be noted that the reported patient effect(s) of angina, and arterial perforation are listed in the xience alpine everolimus eluting coronary stent systems instructions for use (ifu) as a known patient effect(s) of coronary stenting procedures.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.However, the treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.The graftmaster is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the patient presented with a myocardial infarction and thrombectomy was performed.Following, a 3.0x28mm xience alpine stent was implanted in the mid left anterior descending (mlad).Post implantation, a mlad perforation occurred.A 2.8x19mm graftmaster stent was implanted; however, there was still minimal extravasation (leaking) noted.A dilatation balloon catheter was inflated for 5 minutes as treatment and the perforation sealed.During this procedure, the patient experienced chest pain; nitroglycerin was provided.The event resolved without issue.Following, a 2.5x15mm xience alpine stent was implanted in another lesion without issue.The patient is in stable condition and is reportedly doing fine.Per physician, the graftmaster stent did not cause or contribute to complications or adverse events.There was no additional information provided regarding this issue.

• 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: 6831966
• Report Number: 2024168-2017-07119
• Device Sequence Number: 67799
• Product Code: NIQ
• UDI-Device Identifier: 08717648199370
• UDI-Public: 08717648199370
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 1125300-28
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2017
• Initial Report FDA Received Date: 08/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HEPARIN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Weight: 92