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

Catalog Number 1125400-12

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Angina (1710); Low Blood Pressure/ Hypotension (1914); Perforation (2001); Cardiac Tamponade (2226)

Event Date 12/04/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical devices: guide wire: mailman, runthrough, sheath: 6 fr , 5fr jacky, 7fr , stent: 4.0 x 38 mm xience alpine.The device was not returned for evaluation.The reported patient effects of angina, hypotension, perforation and cardiac tamponade are listed in the xience alpine, everolimus eluting coronary stent system, instructions for use as known patient effects of coronary stenting procedures.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.The 4.0 x 38 mm xience alpine is being filed under a separate medwatch report.

Event Description

It was reported the procedure was to treat an eccentric lesion with heavy calcification in the proximal to mid right coronary artery.A 4.0 x 38 mm xience stent was successfully deployed in the more distal segment of the long mid lesion and then the rest of the lesion was covered with a 4.0 x 12 mm xience stent, overlapping the previously deployed stent.Post-dilatation of the middle segment was performed using the stent delivery balloon, but subsequent angiography showed a severe eccentric coronary rupture.The physician commented that the perforation did not occur because of the stents, but because of the calcification and frailty of the vessel.The patient did have significant chest discomfort.A 4.0 mm non-compliant (nc) balloon was inflated across the lesion for tamponade purposes with significant improvement after several inflations.An emergent echocardiogram revealed a moderate concentric pericardial effusion with tamponade features, accompanied by hypotension and requirement of medication.Therefore, a 3.5 x 19 mm graftmaster was used to cover the perforation successfully.Post-dilatation was performed with a 4.0 mm nc balloon.Angiography showed a seal of the perforation.A 4.0 x 8 mm xience was successfully deployed across the ostium and post-dilated.Then, pericardiocentesis was performed with dramatic and immediate response in blood pressure.Angiography revealed very good results with no residual stenosis with good timi 3 flow and no dissections or extravasation.No additional information was provided.

• Brand Name: XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: cathy trent ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 7144633
• MDR Text Key: 95721747
• Report Number: 2024168-2017-10099
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648199608
• UDI-Public: 08717648199608
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/02/2020
• Device Catalogue Number: 1125400-12
• Device Lot Number: 7012541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR