MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SIERRA DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Model Number 1550300-38

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 08/04/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. The reported patient effects of hypotension and pericardial effusion are listed in the xience sierra, everolimus eluting coronary stent system (eecss), electronic instructions for use as known patient effects of coronary stenting procedures. 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 additional two devices are being filed under separate medwatch report numbers.

Event Description

It was reported that on (b)(6) 2020, this was a planned percutaneous coronary intervention of both the left anterior descending (lad) coronary and ramus intermedius arteries with impella support due to severely depressed biventricular function. A non-abbott stent was implanted in the ramus. A prowater guide wire was used to deliver a corsair pro xs microcatheter however, the tip of the microcatheter became separated. Fluoroscopy was used to verify the tip was still on the guide wire. It was then attempted to snare the tip of the micro catheter with a 4mm gooseneck snare, but was unsuccessful. The lad was crossed and pre-dilatation was performed with an unspecified balloon. Shortly thereafter, abrupt hypotension occurred, and a coronary perforation was suspected. A balloon was inflated to temporarily halt flow into the lad in order to stop the bleeding. Pericardiocentesis was attempted, but was unsuccessful. The patient went into cardiac arrest and cardiopulmonary resuscitation was performed for 20 minutes with defibrillation, and the patient was resuscitated. The angiogram showed a large thrombus burden in the left main artery. It was unclear if thrombus was the cause of acute decompensation, or if it developed during prolonged resuscitative effort. Heparin and aspiration thrombectomy were performed with complete resolution of the thrombus. A dissection was made in the lad in order to cross the chronic total occluded (cto) lesion, and was noted as expected without contrast extravasation or evidence of perforation. Intravascular ultrasound (ivus) was then performed, and revealed possible plaque shift in the left circumflex (lcx), which was treated with a 3. 0x38mm xience sierra stent. Due to persistent hypotension requiring medication, a repeat echocardiogram was performed, and revealed enlarging pericardial effusion. Pericardiocentesis was performed with removal of about 500 cc fluid. Patient¿s hemodynamics improved transiently, but remained tenuous and the pericardial drain continued to have significant output. Both a non-abbott stent and a 4. 0x19mm graft master covered stent were implanted in overlapping fashion in the lcx and left main to intentionally exclude the lad in order to stop the bleeding given the unclear source of blood loss. After covered stent placement to stop the flow into the lad, the pericardial drain output slowed as expected. Due to persistent pericardial drain output, heparin effect was reversed with protamine 10 mg. Afterward, the pericardial drain output slowed even further. The patient was transferred to the cardiac care unit (ccu) in tenuous, critical condition. The patient expired the next day on (b)(6) 2020, secondary to right ventricle laceration following withdrawal of care post procedure. It was noted the graft master did not cause the laceration. No additional information was provided.

• Brand Name: XIENCE SIERRA
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 10484841
• MDR Text Key: 214148526
• Report Number: 2024168-2020-07313
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• 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

• Type of Report: Initial,Followup
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 04/01/2021
• Device Model Number: 1550300-38
• Device Catalogue Number: 1550300-38
• Device Lot Number: 0032441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 09/02/2020 Patient Sequence Number: 1