MAUDE Adverse Event Report: ABBOTT VASCULAR ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; BIORESORBABLE SCAFFOLD

Catalog Number 1012463-18

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

Patient Problems Angina (1710); Perforation of Vessels (2135)

Event Date 04/22/2015

Event Type  Injury  

Manufacturer Narrative

Estimated dates.The device was not returned for analysis.A review of the electronic lot history record (elhr) for this product was not performed because the lot number was not reported and the product was not returned for analysis.The reported patient effects of angina and perforation, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use are known adverse events associated with the use of a coronary scaffold in native coronary arteries.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined; however, the subsequent 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.Literature attachment.Article title ¿coronary artery rupture after bioresorbable vascular scaffold implantation resolved with graft stent: optical coherence tomography assessment.¿.

Event Description

It was reported in an article that the patient presented with stable angina.Intravascular ultrasound (ivus) was performed as well as pre-dilatation showing appropriate balloon expansion at 8 atmospheres.A 3.0x18 mm absorb bioresorbable vascular scaffold (bvs) was implanted at 14 atmospheres.Immediately after implant the patient experienced severe chest pain.Angiography showed a perforation within the scaffolded segment.Prolonged balloon inflation was performed as well as reversal of anticoagulation with protamine.After five minutes the perforation was sealed and no further interventions were performed.There were no adverse patient sequela.No additional information was provided.

• Brand Name: ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Type of Device: BIORESORBABLE SCAFFOLD
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 13955569
• MDR Text Key: 289442850
• Report Number: 2024168-2022-03367
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): Y
• Reporter Country Code: SP
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1012463-18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 67 YR
• Patient Sex: Male